FDA Class II · Drug · August 19, 2026
TADALAFIL USP recall — Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
Company / brand: Shoolin Pharma Chem LLP recalls
Official ID D-0760-2026 · Official record ↗
FDA recalls — page 4
2,784 recent recalls from the U.S. Food & Drug Administration in our current data (last 90 days). Showing 901–1,200, newest first.
FDA Class II · Drug · August 19, 2026
SILDENAFIL CITRATE USP recall — Shoolin Pharma Chem LLP
CGMP Deviations:Noted during FDA inspection
Company / brand: Shoolin Pharma Chem LLP recalls
Official ID D-0759-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 20mg (5mg/mL) recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0757-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 10mg (5mg/mL) recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0756-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 7 recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0755-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 5mg (1mg/mL) recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0754-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 2 recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0753-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 0 recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0752-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 9mg (4 recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0751-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 4 recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0750-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 6 recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0749-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 2 recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0748-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
SEMAGLUTIDE 12 recall — Apollo Care, LLC
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Company / brand: Apollo Care recalls
Official ID D-0747-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
Diovan (valsartan) 160 mg recall — Novartis Pharmaceuticals Corporation
Failed Dissolution Specifications
Company / brand: Novartis Pharmaceuticals recalls
Official ID D-0746-2026 · Official record ↗
FDA Not Yet Classified · Food · August 12, 2026
Blank Slate Creamery VEGAN NON-DAIRY FROZEN DESSERT COCONUT FUDGE SANDWICHES recall — Blank Slate Creamery Production
undeclared egg
Company / brand: Blank Slate Creamery Production recalls
Official ID EVT-99560-1p1ou5o · Official record ↗
FDA Class II · Medical device · August 12, 2026
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embol recall — Contego Medical, Inc
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open followi…
Company / brand: Contego Medical recalls
Official ID Z-2911-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Blom-Singer Classic Indwelling Voice Prosthesis recall — Freudenberg Medical, LLC
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flang…
Company / brand: Freudenberg Medical recalls
Official ID Z-2910-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Blom-Singer Classic Indwelling Voice Prosthesis recall — Freudenberg Medical, LLC
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flang…
Company / brand: Freudenberg Medical recalls
Official ID Z-2909-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — TISSIUM SA
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Official ID Z-2908-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — TISSIUM SA
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Official ID Z-2907-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — TISSIUM SA
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Official ID Z-2906-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — TISSIUM SA
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Official ID Z-2905-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — TISSIUM SA
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Official ID Z-2904-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — TISSIUM SA
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Official ID Z-2903-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — TISSIUM SA
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Official ID Z-2902-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — TISSIUM SA
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months. The use of a medical device …
Company / brand: TISSIUM SA recalls
Official ID Z-2901-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
GEM Premier 5000 PAK Part Numbers recall — Instrumentation Laboratory
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result…
Company / brand: Instrumentation Laboratory recalls
Official ID Z-2900-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
GEM Premier 7000 with iQM3 Part Numbers recall — Instrumentation Laboratory
The active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunctio…
Company / brand: Instrumentation Laboratory recalls
Official ID Z-2899-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — United Orthopedic Corp.
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Company / brand: United Orthopedic recalls
Official ID Z-2898-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — United Orthopedic Corp.
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
Company / brand: United Orthopedic recalls
Official ID Z-2897-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
5-PLASMA Bivalirudin Control recall — Aniara Diagnostica LLC
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin…
Company / brand: Aniara Diagnostica recalls
Official ID Z-2896-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
5-PLASMA Bivalirudin Calibrator recall — Aniara Diagnostica LLC
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin…
Company / brand: Aniara Diagnostica recalls
Official ID Z-2895-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
5-PLASMA Bivalirudin AMR Verification Kit recall — Aniara Diagnostica LLC
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin…
Company / brand: Aniara Diagnostica recalls
Official ID Z-2894-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Philips Allura recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls
Official ID Z-2893-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Philips Azurion under the following System Descriptions and corresponding model numbers recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls
Official ID Z-2892-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Philips Allura under the following System Descriptions and corresponding model numbers recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V recalls
Official ID Z-2891-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Atellica CH Urine Albumin REF recall — Siemens Healthcare Diagnostics, Inc.
Processing of urine albumin assay on the CI analyzers may lead to the following issues: Falsely depressed Atellica CH Urea Nitrogen (UN_c) results; Falsely depressed Atellica CH En…
Company / brand: Siemens Healthcare Diagnostics recalls
Official ID Z-2890-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
REF # D23354 recall — Beckman Coulter Inc.
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Company / brand: Beckman Coulter recalls
Official ID Z-2889-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
REF # D23352 recall — Beckman Coulter Inc.
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Company / brand: Beckman Coulter recalls
Official ID Z-2888-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) fo recall — Hardy Diagnostics
Due to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results and may lead to selection of an…
Company / brand: Hardy Diagnostics recalls
Official ID Z-2887-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — United Orthopedic Corp.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic recalls
Official ID Z-2886-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — United Orthopedic Corp.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic recalls
Official ID Z-2885-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — United Orthopedic Corp.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic recalls
Official ID Z-2884-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — United Orthopedic Corp.
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic recalls
Official ID Z-2883-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Happiest Baby recall — Happiest Baby, Inc
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
Company / brand: Happiest Baby recalls
Official ID Z-2882-2026 · Official record ↗
FDA Class III · Medical device · August 12, 2026
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No recall — Siemens Healthcare Diagnostics, Inc.
out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results were not impacted, the overall h…
Company / brand: Siemens Healthcare Diagnostics recalls
Official ID Z-2881-2026 · Official record ↗
FDA Class III · Medical device · August 12, 2026
Syva Emit Disopyramide Assay Enzyme Immunoassay recall — Siemens Healthcare Diagnostics, Inc.
Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not impacted, the overall health risk t…
Company / brand: Siemens Healthcare Diagnostics recalls
Official ID Z-2880-2026 · Official record ↗
FDA Class I · Medical device · August 12, 2026
INFINION CX LEAD KIT recall — Boston Scientific Neuromodulation Corporation
Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate…
Company / brand: Boston Scientific Neuromodulation recalls
Official ID Z-2879-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
GE Healthcare Portrait Core Services SW V 1 recall — GE Medical Systems Information Technologies Inc
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring, missed patient alarms, and/or acc…
Company / brand: GE Medical Systems Information Technologies recalls
Official ID Z-2878-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code recall — Biofire Defense
Firm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic acid-based in vitro diagnostic …
Company / brand: Biofire Defense recalls
Official ID Z-2877-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
GE Healthcare MAC VU360 recall — GE Medical Systems Information Technologies Inc
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of i…
Company / brand: GE Medical Systems Information Technologies recalls
Official ID Z-2876-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Merge OrthoPACS recall — Merge Healthcare, Inc.
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Company / brand: Merge Healthcare recalls
Official ID Z-2875-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Merge PACS recall — Merge Healthcare, Inc.
Thumbnails from a previously opened patient study may be displayed in the Thumbnail Bar while a different patient study is currently open.
Company / brand: Merge Healthcare recalls
Official ID Z-2874-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall — Biomet, Inc.
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused…
Company / brand: Biomet recalls
Official ID Z-2871-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall — Biomet, Inc.
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused…
Company / brand: Biomet recalls
Official ID Z-2870-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall — Biomet, Inc.
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused…
Company / brand: Biomet recalls
Official ID Z-2869-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall — Biomet, Inc.
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused…
Company / brand: Biomet recalls
Official ID Z-2868-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Intramedullary Bone Saw Blade Assembly Model/Catalog Number recall — Biomet, Inc.
Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw Blade Assembly due to potential sterile barrier packaging damage caused…
Company / brand: Biomet recalls
Official ID Z-2867-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
STRYKER PKG recall — Stryker Corporation
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker recalls
Official ID Z-2866-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
STRYKER PKG recall — Stryker Corporation
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker recalls
Official ID Z-2865-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING recall — Stryker Corporation
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker recalls
Official ID Z-2864-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
STRYKER AHTO TUBE SET WITH TIP PACKAGING recall — Stryker Corporation
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker recalls
Official ID Z-2863-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
STRYKER AHTO TUBE SET PACKAGING recall — Stryker Corporation
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker recalls
Official ID Z-2862-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Nuclein LLC
Due to a software issue which may result in false co-infection (e.g., Positive for Flu A, when SARS-CoV-2 is present).
Company / brand: Nuclein recalls
Official ID Z-2861-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C2 recall — Maquet Critical Care AB
Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the patient receiving insufficient …
Company / brand: Maquet Critical Care AB recalls
Official ID Z-2860-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Anti-Torque recall — Innovasis, Inc
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have anti-torque instrument with unde…
Company / brand: Innovasis recalls
Official ID Z-2859-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Medical Action Industries, Inc. 306
Convenience kits contain needle free access device that has an improper seal which may result in doming or tearing of the silicone seal.
Company / brand: Medical Action Industries recalls
Official ID Z-2858-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Oxos Medical Inc
Due to a defective circuit board that overheats
Company / brand: Oxos Medical recalls
Official ID Z-2857-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smar recall — MUNEVO GMBH
A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control…
Company / brand: MUNEVO recalls
Official ID Z-2856-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Nerivio Infinity recall — THERANICA BIOELECTRONICS LTD
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Company / brand: THERANICA BIOELECTRONICS recalls
Official ID Z-2855-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Copan WASP
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
Company / brand: Copan WASP recalls
Official ID Z-2854-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2853-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2852-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2851-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2850-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2849-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2848-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2847-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2846-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2845-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2844-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2843-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2842-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Brand Name recall — Pride Mobility Products Corp.
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the…
Company / brand: Pride Mobility Products recalls
Official ID Z-2841-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN recall — Boston Scientific Corporation
Potential for breach in sterile barrier of device packaging.
Company / brand: Boston Scientific recalls
Official ID Z-2840-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN recall — Boston Scientific Corporation
Potential for breach in sterile barrier of device packaging.
Company / brand: Boston Scientific recalls
Official ID Z-2839-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN recall — Boston Scientific Corporation
Potential for breach in sterile barrier of device packaging.
Company / brand: Boston Scientific recalls
Official ID Z-2838-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Kingfisher Compact Individual First Aid Kit recall — INTEGRATED MEDCRAFT LLC
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Company / brand: INTEGRATED MEDCRAFT recalls
Official ID Z-2837-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
FORWARD Oral Airway Kit (OPA Sizes 5 recall — INTEGRATED MEDCRAFT LLC
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Company / brand: INTEGRATED MEDCRAFT recalls
Official ID Z-2836-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
Charger for the Therabody Theragun recall — Therabody, Inc
Charging cradle for the device may overheat while charging the device's removable battery pack, presenting risk of thermal event (fire). Firm has received reports alleging the prod…
Company / brand: Therabody recalls
Official ID Z-2835-2026 · Official record ↗
FDA Class II · Medical device · August 12, 2026
REMISOL Advance with Software Version 2 recall — Beckman Coulter Biomedical GmbH
Due to software issues where does not handle combo assay results. The software may replace the final combo test result with one of the sub-results resulting in incorrect reporting …
Company / brand: Beckman Coulter Biomedical recalls
Official ID Z-2834-2026 · Official record ↗
FDA Class I · Medical device · August 12, 2026
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma recall — AVID Medical, Inc.
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifol…
Company / brand: AVID Medical recalls
Official ID Z-2798-2026 · Official record ↗
FDA Class I · Medical device · August 12, 2026
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma recall — AVID Medical, Inc.
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifol…
Company / brand: AVID Medical recalls
Official ID Z-2797-2026 · Official record ↗
FDA Class I · Medical device · August 12, 2026
Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma recall — AVID Medical, Inc.
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifol…
Company / brand: AVID Medical recalls
Official ID Z-2796-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Blank Slate Creamery VEGAN NON-DAIRY FROZEN DESSERT COCONUT FUDGE SANDWICHES recall — Blank Slate Creamery Production
undeclared egg
Company / brand: Blank Slate Creamery Production recalls
Official ID H-1272-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
KC Everyday Mac & Cheese recall — Kerry, Inc
Undeclared allergen (egg)
Company / brand: Kerry recalls
Official ID H-1237-2026 · Official record ↗
FDA Class III · Food · August 12, 2026
Kanni Delight 31/40 Fresh Frozen Vannamei White Shrimp IQF recall — CAMPO RICO FOODS LLC
Nitrofurans detected in product
Company / brand: CAMPO RICO FOODS recalls
Official ID H-1236-2026 · Official record ↗
FDA Class II · Food · August 12, 2026
Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree recall — PT Organics Limited
Possible foreign object (thin, soft plastic strands).
Company / brand: PT Organics recalls
Official ID H-1223-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Zen Principle Naturals Moringa Leaf Powder dietary supplement recall — FACTORY6, INC.
Possible Salmonella in Moringa Leaf Powder product.
Company / brand: FACTORY6 recalls
Official ID H-1222-2026 · Official record ↗
FDA Class II · Food · August 12, 2026
Ultimate Mother's Day Wangshin Doenjang Aged 3 Years 9 oz recall — JINA F&C
Product label allergen "contains" statement does not include anchovy(fish)
Company / brand: JINA F&C recalls
Official ID H-1221-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Requeson recall — La Colonia Foods Llc
Products may be contaminated with Listeria monocytogenes.
Company / brand: La Colonia Foods recalls
Official ID H-1220-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Selectos Latinos Requeson Mexicano Mexican Cottage Cheese recall — La Colonia Foods Llc
Products may be contaminated with Listeria monocytogenes.
Company / brand: La Colonia Foods recalls
Official ID H-1219-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Selectos Latinos Requeson Salvadoreno Ricotta Style Salvadorean Cheese recall — La Colonia Foods Llc
Products may be contaminated with Listeria monocytogenes.
Company / brand: La Colonia Foods recalls
Official ID H-1218-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
La Colonia Foods Salvadoreno Requeson Soft Ricotta recall — La Colonia Foods Llc
Products may be contaminated with Listeria monocytogenes.
Company / brand: La Colonia Foods recalls
Official ID H-1217-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1216-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1215-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1214-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1213-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1212-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1211-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1210-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1209-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1208-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1207-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1206-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1205-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1204-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1203-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1202-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1201-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1200-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Clover Hill Dairy LLP recall — Clover Hill Dairy, LLC
Product contaminated with Listeria monocytogenes.
Company / brand: Clover Hill Dairy recalls
Official ID H-1199-2026 · Official record ↗
FDA Class II · Food · August 12, 2026
FLOUNDER SASHIMI WITH SAUCE recall — Eunha Fisheries Co., LTD
Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
Company / brand: Eunha Fisheries Co recalls
Official ID H-1198-2026 · Official record ↗
FDA Class II · Food · August 12, 2026
Sliced Korean Halibut with Soy sauce recall — Eunha Fisheries Co., LTD
Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
Company / brand: Eunha Fisheries Co recalls
Official ID H-1197-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Ashfiat Alharamain Energy Support 250ml/8fl recall — AKKARCO LLC
Undeclared tadalafil
Company / brand: AKKARCO recalls
Official ID H-1196-2026 · Official record ↗
FDA Class II · Food · August 12, 2026
Big Way Hot Pot "Hot Pot Miso Paste" recall — Big Way Ca Inc
Undeclared milk from lactose.
Company / brand: Big Way Ca recalls
Official ID H-1195-2026 · Official record ↗
FDA Class II · Food · August 12, 2026
"***Hondashi 0 recall — Pack'n Fresh LLC
Allergen missing from contains statement: fish
Company / brand: Pack'n Fresh recalls
Official ID H-1194-2026 · Official record ↗
FDA Class II · Food · August 12, 2026
Flexible food pouch (3-layer foil recall — CHEER PACK
Flexible food pouch may release thin plastic strips into food.
Company / brand: CHEER PACK recalls
Official ID H-1193-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
Spicy Breakfast Burrito sold under the following brand names recall — M.G. Foods, Inc.
Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
Company / brand: M.G. Foods recalls
Official ID H-1192-2026 · Official record ↗
FDA Class II · Drug · August 12, 2026
Mirabegron Extended-Release Tablets recall — Zydus Pharmaceuticals (USA) Inc
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Company / brand: Zydus Pharmaceuticals (USA) recalls
Official ID D-0745-2026 · Official record ↗
FDA Class I · Drug · August 12, 2026
Cyclophosphamide for Injection recall — Sunny Pharmtech Inc.
Presence of Particulate Matter; identified as stainless steel
Company / brand: Sunny Pharmtech recalls
Official ID D-0744-2026 · Official record ↗
FDA Class I · Drug · August 12, 2026
Cyclophosphamide for Injection recall — Sunny Pharmtech Inc.
Presence of Particulate Matter; identified as stainless steel
Company / brand: Sunny Pharmtech recalls
Official ID D-0743-2026 · Official record ↗
FDA Class III · Drug · August 12, 2026
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag recall — Central Admixture Pharmacy Services Inc
Incorrect Product Formulation
Company / brand: Central Admixture Pharmacy Services recalls
Official ID D-0740-2026 · Official record ↗
FDA Class II · Drug · August 12, 2026
Dicyclomine Hydrochloride Capsules recall — Aurobindo Pharma USA Inc
shortfill; reports of empty capsules.
Company / brand: Aurobindo Pharma USA recalls
Official ID D-0733-2026 · Official record ↗
FDA Not Yet Classified · Drug · August 5, 2026
Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC
Failed impurity/degradation specification:12M Long-term Stability conditions (25 ¿2 ¿C/60 ¿5%RH), an OOS result observed in Related substance test analysis w.r.t Impurity II, Impur…
Company / brand: Ascend Laboratories recalls
Official ID EVT-99421-191x326 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 150mm recall — Stryker GmbH
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker recalls
Official ID Z-2833-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 120mm recall — Stryker GmbH
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker recalls
Official ID Z-2832-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 90mm recall — Stryker GmbH
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker recalls
Official ID Z-2831-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 60mm recall — Stryker GmbH
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker recalls
Official ID Z-2830-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 50mm recall — Stryker GmbH
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker recalls
Official ID Z-2829-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm recall — Stryker GmbH
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker recalls
Official ID Z-2828-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Stryker Hoffmann II Connecting Rod Micro 3 x 30mm recall — Stryker GmbH
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker recalls
Official ID Z-2827-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Brand Name recall — Instrumentation Laboratory
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Company / brand: Instrumentation Laboratory recalls
Official ID Z-2826-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Brand Name recall — Instrumentation Laboratory
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Company / brand: Instrumentation Laboratory recalls
Official ID Z-2825-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Brand Name recall — Instrumentation Laboratory
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Company / brand: Instrumentation Laboratory recalls
Official ID Z-2824-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Brand Name recall — Instrumentation Laboratory
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Company / brand: Instrumentation Laboratory recalls
Official ID Z-2823-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Brand Name recall — Instrumentation Laboratory
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Company / brand: Instrumentation Laboratory recalls
Official ID Z-2822-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
GEM Premier 5000 with IQM2 Model/Catalog Number recall — Instrumentation Laboratory
Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
Company / brand: Instrumentation Laboratory recalls
Official ID Z-2821-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
OsteoBallast recall — IsoTis OrthoBiologics, Inc.
Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were filled with approx. 4.5 cc…
Company / brand: IsoTis OrthoBiologics recalls
Official ID Z-2820-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2819-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2818-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2817-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2816-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2815-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2814-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2813-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lid…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2812-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
EOPA 3D Arterial Cannula 22FR recall — Medtronic Perfusion Systems
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…
Company / brand: Medtronic Perfusion Systems recalls
Official ID Z-2811-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
EOPA 3D Arterial Cannula DIL TIP 22FR recall — Medtronic Perfusion Systems
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…
Company / brand: Medtronic Perfusion Systems recalls
Official ID Z-2810-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR recall — Medtronic Perfusion Systems
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…
Company / brand: Medtronic Perfusion Systems recalls
Official ID Z-2809-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR recall — Medtronic Perfusion Systems
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…
Company / brand: Medtronic Perfusion Systems recalls
Official ID Z-2808-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR recall — Medtronic Perfusion Systems
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…
Company / brand: Medtronic Perfusion Systems recalls
Official ID Z-2807-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR recall — Medtronic Perfusion Systems
Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks associated with this condition may include hypovolemia, vessel laceration or perforati…
Company / brand: Medtronic Perfusion Systems recalls
Official ID Z-2806-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
M5 Corpus Power Wheelchair REF recall — Permobil Inc
This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, a…
Company / brand: Permobil recalls
Official ID Z-2805-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm recall — Argon Medical Devices, Inc
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking a…
Company / brand: Argon Medical Devices recalls
Official ID Z-2804-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
L-Cath PICC S/L Peripherally Inserted Central Catheter recall — Argon Medical Devices, Inc
Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking a…
Company / brand: Argon Medical Devices recalls
Official ID Z-2803-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2802-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2801-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2800-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as recall — Windstone Medical Packaging, Inc.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998…
Company / brand: Windstone Medical Packaging recalls
Official ID Z-2799-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF recall — Permobil Inc
This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the use…
Company / brand: Permobil recalls
Official ID Z-2795-2026 · Official record ↗
FDA Class I · Medical device · August 5, 2026
Pack Angiography NCMC 3/Cs BANNER recall — Medical Action Industries, Inc. 306
Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be introduced into blood…
Company / brand: Medical Action Industries recalls
Official ID Z-2792-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Power Over Fiber Base Module recall — Terex Utilities
Device not certified - no laser product report was filed with CDRH prior to distribution. Product label incorrectly states device is "Class IV", although Class 1 is appropriate for…
Company / brand: Terex Utilities recalls
Official ID Z-2745-2026 · Official record ↗
FDA Class I · Medical device · August 5, 2026
Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous recall — ResMed Ltd.
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
Company / brand: ResMed recalls
Official ID Z-2735-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity recall — PHILIPS MEDICAL SYSTEMS
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i…
Company / brand: PHILIPS MEDICAL SYSTEMS recalls
Official ID Z-2652-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
IQon Spectral CT IQon Spectral CT Upgrades recall — PHILIPS MEDICAL SYSTEMS
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i…
Company / brand: PHILIPS MEDICAL SYSTEMS recalls
Official ID Z-2651-2026 · Official record ↗
FDA Class II · Medical device · August 5, 2026
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 B recall — PHILIPS MEDICAL SYSTEMS
The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result i…
Company / brand: PHILIPS MEDICAL SYSTEMS recalls
Official ID Z-2650-2026 · Official record ↗
FDA Class II · Food · August 5, 2026
DQ Chocolate Reduced Fat Ice Cream Mix recall — Galliker Dairy Co, Inc.
Foreign material found in product (identified as metal shavings)
Company / brand: Galliker Dairy Co recalls
Official ID H-1191-2026 · Official record ↗
FDA Class II · Food · August 5, 2026
Mellish Island Super Skin recall — Mellish Island Corp
Firm's finished product label does not declare the source of marine collagen which was determined to be fish.
Company / brand: Mellish Island recalls
Official ID H-1190-2026 · Official record ↗
FDA Class I · Food · August 5, 2026
Requeson (soft ricotta) 1 lb recall — Nelson & Isa Lacteos LLC
Products may be contaminated with Listeria monocytogenes.
Company / brand: Nelson & Isa Lacteos recalls
Official ID H-1189-2026 · Official record ↗
FDA Class III · Drug · August 5, 2026
Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Company / brand: Ascend Laboratories recalls
Official ID D-0739-2026 · Official record ↗
FDA Class III · Drug · August 5, 2026
Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Company / brand: Ascend Laboratories recalls
Official ID D-0738-2026 · Official record ↗
FDA Class III · Drug · August 5, 2026
Dabigatran Etexilate Capsules recall — Ascend Laboratories, LLC
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Company / brand: Ascend Laboratories recalls
Official ID D-0737-2026 · Official record ↗
FDA Class II · Drug · August 5, 2026
Mycophenolate Mofetil for Injection USP recall — MYLAN PHARMACEUTICALS INC
Presence of precipitate
Company / brand: MYLAN PHARMACEUTICALS recalls
Official ID D-0734-2026 · Official record ↗
FDA Class II · Drug · August 5, 2026
Azelaic Acid Gel recall — Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Company / brand: Glenmark Pharmaceuticals recalls
Official ID D-0731-2026 · Official record ↗
FDA Class II · Drug · August 5, 2026
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution recall — MICRO LABS USA INC
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Company / brand: MICRO LABS USA recalls
Official ID D-0730-2026 · Official record ↗
FDA Not Yet Classified · Drug · July 29, 2026
Glycopyrrolate Oral Solution recall — Precision Dose Inc.
Due to an out-of-specification result for an unidentified impurity detected during routine stability testing.
Company / brand: Precision Dose recalls
Official ID EVT-99388-g6s9bf · Official record ↗
FDA Not Yet Classified · Drug · July 29, 2026
Trokendi XR recall — Supernus Pharmaceuticals, Inc.
Failed Dissolution Specifications
Company / brand: Supernus Pharmaceuticals recalls
Official ID EVT-99375-1qlo6cy · Official record ↗
FDA Class II · Medical device · July 29, 2026
Flexible Hystero-Fiberscope Kits REF recall — Karl Storz Endoscopy
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could …
Company / brand: Karl Storz Endoscopy recalls
Official ID Z-2794-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
SafeOp Patient Interface recall — Alphatec Spine, Inc.
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as sys…
Company / brand: Alphatec Spine recalls
Official ID Z-2793-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline medical convenience kits labeled as recall — Medline Industries, LP
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Company / brand: Medline Industries recalls
Official ID Z-2791-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline medical convenience kits labeled as recall — Medline Industries, LP
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Company / brand: Medline Industries recalls
Official ID Z-2790-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline medical convenience kits labeled as recall — Medline Industries, LP
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Company / brand: Medline Industries recalls
Official ID Z-2789-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline medical convenience kits labeled as recall — Medline Industries, LP
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Company / brand: Medline Industries recalls
Official ID Z-2788-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Company / brand: Medline Industries recalls
Official ID Z-2787-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Company / brand: Medline Industries recalls
Official ID Z-2786-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Company / brand: Medline Industries recalls
Official ID Z-2785-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Company / brand: Medline Industries recalls
Official ID Z-2784-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Company / brand: Medline Industries recalls
Official ID Z-2783-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Company / brand: Medline Industries recalls
Official ID Z-2782-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Company / brand: Medline Industries recalls
Official ID Z-2781-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Company / brand: Medline Industries recalls
Official ID Z-2780-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16 recall — Medline Industries, LP
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Company / brand: Medline Industries recalls
Official ID Z-2779-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
MiniMed Go App recall — Medtronic MiniMed, Inc.
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be t…
Company / brand: Medtronic MiniMed recalls
Official ID Z-2778-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Emano Flow with software version v2 recall — Emano Metrics, Inc.
Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validat…
Company / brand: Emano Metrics recalls
Official ID Z-2777-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Olympus High Flow Insufflation Unit - UHI-4 recall — Olympus Corporation of the Americas
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Company / brand: Olympus of the Americas recalls
Official ID Z-2776-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
SnapshotGLO Wound Imaging Device recall — KENT IMAGING, INC.
The software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully discharged into a low-power "shippin…
Company / brand: KENT IMAGING recalls
Official ID Z-2775-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Pipeline Flex Embolization Device with Shield Technology recall — Micro Therapeutics, Inc.
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Company / brand: Micro Therapeutics recalls
Official ID Z-2774-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Pipeline Flex Embolization Device with Shield Technology recall — Micro Therapeutics, Inc.
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
Company / brand: Micro Therapeutics recalls
Official ID Z-2773-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Halyard STANDARD LINE INSERTION PACK recall — AVID Medical, Inc.
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.
Company / brand: AVID Medical recalls
Official ID Z-2772-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Boston Scientific TheraSphere 360 Y-90 Management Platform recall — Boston Scientific Corporation
Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu…
Company / brand: Boston Scientific recalls
Official ID Z-2771-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Penumbra System RED 68 Reperfusion Catheter REF recall — Penumbra, Inc.
Due to manufacturing issues, reperfusion catheters may fractures
Company / brand: Penumbra recalls
Official ID Z-2770-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Brand Name recall — Prismatik Dentalcraft, Inc.
Due to device not having FDA Clearance
Company / brand: Prismatik Dentalcraft recalls
Official ID Z-2769-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Ventriculostomy Kit recall — Medtronic Neurosurgery
Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices …
Company / brand: Medtronic Neurosurgery recalls
Official ID Z-2768-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
3mensio Workstation (Vascular Fenestrated) software recall — PIE Medical Imaging B.V.
User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d…
Company / brand: PIE Medical Imaging B.V recalls
Official ID Z-2767-2026 · Official record ↗
FDA Class I · Medical device · July 29, 2026
MEDLINE medical procedure convenience kit labeled as recall — Medline Industries, LP
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that co…
Company / brand: Medline Industries recalls
Official ID Z-2765-2026 · Official record ↗
FDA Class I · Medical device · July 29, 2026
MEDLINE medical procedure convenience kit labeled as recall — Medline Industries, LP
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that co…
Company / brand: Medline Industries recalls
Official ID Z-2764-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Halyard EYE PACK recall — AVID Medical, Inc.
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
Company / brand: AVID Medical recalls
Official ID Z-2763-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
SeaSpine Polyaxial Head REF Number recall — SEASPINE ORTHOPEDICS CORPORATION
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Company / brand: SEASPINE ORTHOPEDICS recalls
Official ID Z-2762-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Olympus 4K UHD LCD Monitor recall — Olympus Corporation of the Americas
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Company / brand: Olympus of the Americas recalls
Official ID Z-2761-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Power F2 Powered Fastening System recall — Ferno-Washington Inc
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may b…
Company / brand: Ferno-Washington recalls
Official ID Z-2760-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
Hotline Fluid Warming Set recall — ICU Medical Inc.
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing t…
Company / brand: ICU Medical recalls
Official ID Z-2759-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM recall — Paragon 28, Inc.
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Company / brand: Paragon 28 recalls
Official ID Z-2758-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
FARADRIVE STEERABLE SHEATH CLEAR OUS recall — Boston Scientific Corporation
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…
Company / brand: Boston Scientific recalls
Official ID Z-2757-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
FARADRIVE STEERABLE SHEATH (CLEAR) - US recall — Boston Scientific Corporation
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…
Company / brand: Boston Scientific recalls
Official ID Z-2756-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
FARADRIVE STEERABLE SHEATH CLEAR recall — Boston Scientific Corporation
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…
Company / brand: Boston Scientific recalls
Official ID Z-2755-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
FARADRIVE Steerable Sheath Clear IDE recall — Boston Scientific Corporation
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orient…
Company / brand: Boston Scientific recalls
Official ID Z-2754-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
FARASTAR Ablation Generator EU recall — Boston Scientific Corporation
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Company / brand: Boston Scientific recalls
Official ID Z-2753-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
FARASTAR PFA Generator recall — Boston Scientific Corporation
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Company / brand: Boston Scientific recalls
Official ID Z-2752-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
FARASTAR Pulsed Field Ablation Generator recall — Boston Scientific Corporation
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Company / brand: Boston Scientific recalls
Official ID Z-2751-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
FARASTAR Ablation Generator EU recall — Boston Scientific Corporation
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Company / brand: Boston Scientific recalls
Official ID Z-2750-2026 · Official record ↗
FDA Class I · Medical device · July 29, 2026
MEDLINE convenience kits labeled as recall — Medline Industries, LP
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Brau…
Company / brand: Medline Industries recalls
Official ID Z-2749-2026 · Official record ↗
FDA Class I · Medical device · July 29, 2026
MEDLINE convenience kits labeled as recall — Medline Industries, LP
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Brau…
Company / brand: Medline Industries recalls
Official ID Z-2748-2026 · Official record ↗
FDA Class I · Medical device · July 29, 2026
MEDLINE ANTERIOR HIP recall — Medline Industries, LP
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Brau…
Company / brand: Medline Industries recalls
Official ID Z-2747-2026 · Official record ↗
FDA Class II · Medical device · July 29, 2026
The intended use is to be paired with a weapon for aiming purposes recall — Wilcox Industries Corp.
Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all units should be retu…
Company / brand: Wilcox Industries recalls
Official ID Z-2675-2026 · Official record ↗
FDA Class II · Food · July 29, 2026
Wonton Wrappers packed into clear flexible plastic bag and sold as 40 units (16oz bags)/ca recall — Man Fon, Inc.
No labeling. Undeclared wheat and colors: Yellow#5, Yellow#6.
Company / brand: Man Fon recalls
Official ID H-1188-2026 · Official record ↗
FDA Class II · Food · July 29, 2026
Man Fon Inc recall — Man Fon, Inc.
Undeclared colors: Yellow#5, and Yellow#6.
Company / brand: Man Fon recalls
Official ID H-1187-2026 · Official record ↗
FDA Class I · Food · July 29, 2026
Fusia recall — GELLERT GLOBAL GROUP
Undeclared Allergen (Fish)
Company / brand: GELLERT GLOBAL GROUP recalls
Official ID H-1186-2026 · Official record ↗
FDA Class I · Food · July 29, 2026
1 recall — Total Nutrition Inc
Contaminated with Salmonella
Company / brand: Total Nutrition recalls
Official ID H-1185-2026 · Official record ↗
FDA Class III · Food · July 29, 2026
Island Pacific IMITATION CRAB FLAKES NET WT recall — Shandong Ling Xian Food Co.,LTD
Undeclared sodium tripolyphosphate (STTP)
Company / brand: Shandong Ling Xian Food Co recalls
Official ID H-1184-2026 · Official record ↗
FDA Class III · Food · July 29, 2026
NAUTILUS IMITATION CRAB STICKS NET WT recall — Shandong Ling Xian Food Co.,LTD
Undeclared sodium tripolyphosphate (STTP)
Company / brand: Shandong Ling Xian Food Co recalls
Official ID H-1183-2026 · Official record ↗
FDA Class III · Food · July 29, 2026
Island Pacific IMITATION CRAB STICKS NET WT recall — Shandong Ling Xian Food Co.,LTD
Undeclared sodium tripolyphosphate (STTP)
Company / brand: Shandong Ling Xian Food Co recalls
Official ID H-1182-2026 · Official record ↗
FDA Class I · Food · July 29, 2026
Organic Moringa Powder recall — Green Jeeva LLC
Moringa Powder ingredient positive for salmonella
Company / brand: Green Jeeva recalls
Official ID H-1180-2026 · Official record ↗
FDA Class II · Food · July 29, 2026
Brooklyn Roasting Company Pasteurized Cold Brew Concentrate recall — Brooklyn Roasting Works LLC
Ambient storage of the product may lead to Clostridium botulinum toxin formation.
Company / brand: Brooklyn Roasting Works recalls
Official ID H-1179-2026 · Official record ↗
FDA Class I · Food · July 29, 2026
Modern Warrior Ready recall — Modern Warrior Life, LLC
FDA analysis revealed the presence of unapproved ingredients including tianeptine, 1,4 DMAA, and aniracetam.
Company / brand: Modern Warrior Life recalls
Official ID H-1178-2026 · Official record ↗
FDA Class II · Food · July 29, 2026
Vintage Roots Root Beer Syrup recall — Vintage Roots LLC
Unapproved food additive: sassafras bark.
Company / brand: Vintage Roots recalls
Official ID H-1177-2026 · Official record ↗
FDA Class III · Drug · July 29, 2026
Trokendi XR recall — Supernus Pharmaceuticals, Inc.
Failed Dissolution Specifications
Company / brand: Supernus Pharmaceuticals recalls
Official ID D-0758-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Divalproex Sodium Delayed-Release Tablets recall — Bionpharma Inc.
Presence of Foreign Tablets/Capsules
Company / brand: Bionpharma recalls
Official ID D-0742-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Glycopyrrolate Oral Solution recall — Precision Dose Inc.
Failed Impurities/Degradation Specifications
Company / brand: Precision Dose recalls
Official ID D-0741-2026 · Official record ↗
FDA Class III · Drug · July 29, 2026
Dabigatran etexilate Capsules recall — Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testin…
Company / brand: Ascend Laboratories recalls
Official ID D-0736-2026 · Official record ↗
FDA Class III · Drug · July 29, 2026
Dabigatran etexilate Capsules recall — Ascend Laboratories, LLC
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testin…
Company / brand: Ascend Laboratories recalls
Official ID D-0735-2026 · Official record ↗
FDA Class I · Drug · July 29, 2026
Cetirizine Hydrochloride Tablets USP 5 mg recall — JB Chemicals and Pharmaceuticals Ltd
Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to …
Company / brand: JB Chemicals and Pharmaceuticals recalls
Official ID D-0732-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Xylocaine (lidocaine HCl Injection recall — Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
Company / brand: Fresenius Kabi USA recalls
Official ID D-0729-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Xylocaine (lidocaine HCl Injection recall — Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
Company / brand: Fresenius Kabi USA recalls
Official ID D-0728-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Naropin (ropivacaine hydrochloride Injection recall — Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
Company / brand: Fresenius Kabi USA recalls
Official ID D-0727-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Lidocaine HCl Injection recall — Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in products
Company / brand: Fresenius Kabi USA recalls
Official ID D-0726-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Glycopyrrolate Injection recall — Fresenius Kabi USA, LLC
Presence of Particulate Matter: Hair was found in product
Company / brand: Fresenius Kabi USA recalls
Official ID D-0725-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Rising recall — Rising Pharma Holding, Inc.
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
Company / brand: Rising Pharma Holding recalls
Official ID D-0724-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co recalls
Official ID D-0722-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Rohto Cooling Eye Drops Dry Aid (povidone 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co recalls
Official ID D-0721-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Rohto Cooling Eye Drops Dry Aid (povidone 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co recalls
Official ID D-0720-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Rohto Cooling Eye Drops Digi Eye (hypromellose 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co recalls
Official ID D-0719-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co recalls
Official ID D-0718-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co recalls
Official ID D-0717-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co recalls
Official ID D-0716-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0 recall — Rohto-Mentholatum (Vietnam) Co., Ltd.
Lack of Assurance of Sterility
Company / brand: Rohto-Mentholatum (Vietnam) Co recalls
Official ID D-0715-2026 · Official record ↗
FDA Class III · Drug · July 29, 2026
Lidolog Kit recall — Asclemed USA Inc.
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Company / brand: Asclemed USA recalls
Official ID D-0713-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Amlodipine and Olmesartan Medoxomil Tablets recall — Ascend Laboratories, LLC
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Company / brand: Ascend Laboratories recalls
Official ID D-0712-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0711-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0710-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0709-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0708-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0707-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0706-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0705-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0704-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0703-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0702-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0701-2026 · Official record ↗
FDA Class II · Drug · July 29, 2026
Levothyroxine Sodium Tablets recall — Major Pharmaceuticals
Subpotent Drug
Company / brand: Major Pharmaceuticals recalls
Official ID D-0700-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
ST AIA-Pack Testosterone recall — Tosoh Bioscience Inc
The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated…
Company / brand: Tosoh Bioscience recalls
Official ID Z-2746-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Photera 600 3-D recall — Daavlin Distributing Company
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Company / brand: Daavlin Distributing Company recalls
Official ID Z-2744-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Photera 600 recall — Daavlin Distributing Company
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Company / brand: Daavlin Distributing Company recalls
Official ID Z-2743-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Photera 400 recall — Daavlin Distributing Company
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Company / brand: Daavlin Distributing Company recalls
Official ID Z-2742-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000 recall — Maquet Cardiovascular, LLC
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-2878…
Company / brand: Maquet Cardiovascular recalls
Official ID Z-2741-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Brand Name recall — 3B Medical, Inc.
Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).
Company / brand: 3B Medical recalls
Official ID Z-2740-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Medtronic Bio-Medicus Adult Cannula Kit recall — Medtronic Perfusion Systems
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Company / brand: Medtronic Perfusion Systems recalls
Official ID Z-2739-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Medtronic DLP One-Piece Pediatric Arterial Cannula recall — Medtronic Perfusion Systems
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood.
Company / brand: Medtronic Perfusion Systems recalls
Official ID Z-2738-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ616 recall — Medline Industries, LP
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of produc…
Company / brand: Medline Industries recalls
Official ID Z-2737-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267 recall — Medline Industries, LP
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of produc…
Company / brand: Medline Industries recalls
Official ID Z-2736-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Papablic Replacement Brush Heads recall — Papablic Inc
Potential for brush heads to break.
Company / brand: Papablic recalls
Official ID Z-2734-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Papablic Replacement Brush Heads recall — Papablic Inc
Potential for brush heads to break.
Company / brand: Papablic recalls
Official ID Z-2733-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Orthofix MINIRAIL recall — Orthofix U.S. LLC
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Company / brand: Orthofix U.S recalls
Official ID Z-2732-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF recall — Orthofix U.S. LLC
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Company / brand: Orthofix U.S recalls
Official ID Z-2731-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Orthofix MINIRAIL recall — Orthofix U.S. LLC
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Company / brand: Orthofix U.S recalls
Official ID Z-2730-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Orthofix MINIRAIL recall — Orthofix U.S. LLC
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111
Company / brand: Orthofix U.S recalls
Official ID Z-2729-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Optima XR240amx recall — GE Medical Systems, LLC
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been…
Company / brand: GE Medical Systems recalls
Official ID Z-2728-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Optima XR220amx recall — GE Medical Systems, LLC
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been…
Company / brand: GE Medical Systems recalls
Official ID Z-2727-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Optima XR200amx recall — GE Medical Systems, LLC
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been…
Company / brand: GE Medical Systems recalls
Official ID Z-2726-2026 · Official record ↗
FDA Class II · Medical device · July 22, 2026
Rapid Refill Continuous Injection System recall — Boston Scientific Corporation
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loo…
Company / brand: Boston Scientific recalls
Official ID Z-2725-2026 · Official record ↗
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
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FDA last checked October 22, 2026 at 12:00 PM UTC.