1,111 recent medical device recalls in our current data. Showing the 200 most recent.
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Affected product: Cardinal Health Presource Kits
Official ID Z-2949-2026 · Official record ↗
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Affected product: Cardinal Health Presource Kits
Official ID Z-2948-2026 · Official record ↗
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Affected product: Cardinal Health Presource Kits
Official ID Z-2947-2026 · Official record ↗
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Affected product: Cardinal Health Presource Kits
Official ID Z-2946-2026 · Official record ↗
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Affected product: Cardinal Health Presource Kits
Official ID Z-2945-2026 · Official record ↗
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Affected product: Cardinal Health Presource Kits
Official ID Z-2944-2026 · Official record ↗
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Affected product: Cardinal Health Presource Kits
Official ID Z-2943-2026 · Official record ↗
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Affected product: Cardinal Health Presource Kits
Official ID Z-2942-2026 · Official record ↗
Products may not have received adequate sterilization processing.
Company / brand: BD SWITZERLAND SARL
Affected product: 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code
Official ID Z-2941-2026 · Official record ↗
A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector resulting in CO2 leaking into the r…
Company / brand: Erbe USA
Affected product: ERBECRYO 2 Cryosurgical Unit Model/Catalog Number
Official ID Z-2938-2026 · Official record ↗
The use of a non-validated rework process for assay reagents which could lead to missed diagnosis of renal disease, inappropriate treatment decisions, or inappropriate monitoring o…
Company / brand: Bioporto Diagnostics A/S
Affected product: ProNephro AKI (NGAL) Reagent Kit (100 tests)
Official ID Z-2937-2026 · Official record ↗
Due to increase in false negative results
Company / brand: BioFire Diagnostics
Affected product: BIOFIRE Respiratory Panel 2
Official ID Z-2936-2026 · Official record ↗
Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain implants that are 12mm in length instead of 14mm as the labeling would suggest…
Company / brand: Straumann USA
Affected product: Straumann Bone Level Tapered (BLT) Implant
Official ID Z-2935-2026 · Official record ↗
The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure Hinge plateau. The incorrect plateau could lead to a prolonged or modified s…
Company / brand: Waldemar Link & Co. KG (Mfg Site)
Affected product: Endo-Model
Official ID Z-2934-2026 · Official record ↗
There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions for both the patient and the hea…
Company / brand: OBP Medical
Affected product: OBP Medical
Official ID Z-2933-2026 · Official record ↗
Two software related issues: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss…
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Affected product: Philips Azurion
Official ID Z-2932-2026 · Official record ↗
Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropria…
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Affected product: Philips Azurion Rystem
Official ID Z-2931-2026 · Official record ↗
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Company / brand: Terumo Medical
Affected product: GLIDESHEATH SLENDER A-KIT 6F 10CM
Official ID Z-2930-2026 · Official record ↗
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the incorrect implant is installed, the i…
Company / brand: Straumann USA
Affected product: GM Helix Implant
Official ID Z-2929-2026 · Official record ↗
Firmware issue potentially leading to loss of geometry movements.
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Affected product: Allura Xper FD
Official ID Z-2928-2026 · Official record ↗
Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not positive to ATCC13102 within 60 Seconds.
Company / brand: Remel Europe
Affected product: Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL
Official ID Z-2927-2026 · Official record ↗
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Company / brand: Medline Industries
Affected product: Medline Micro-Kill Bleach Germicidal Bleach Wipes
Official ID Z-2926-2026 · Official record ↗
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Company / brand: Medline Industries
Affected product: Medline Micro-Kill Bleach Germicidal Bleach Wipes
Official ID Z-2925-2026 · Official record ↗
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Company / brand: Medline Industries
Affected product: Medline Micro-Kill Bleach Germicidal Bleach Wipes
Official ID Z-2924-2026 · Official record ↗
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Company / brand: Medline Industries
Affected product: Medline Micro-Kill Bleach Germicidal Bleach Wipes
Official ID Z-2923-2026 · Official record ↗
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…
Company / brand: Covidien
Affected product: Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
Official ID Z-2922-2026 · Official record ↗
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…
Company / brand: Covidien
Affected product: Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
Official ID Z-2921-2026 · Official record ↗
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…
Company / brand: Covidien
Affected product: Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU
Official ID Z-2920-2026 · Official record ↗
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…
Company / brand: Covidien
Affected product: V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY P
Official ID Z-2919-2026 · Official record ↗
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of v…
Company / brand: Covidien
Affected product: V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 G
Official ID Z-2918-2026 · Official record ↗
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Company / brand: Galt Medical
Affected product: Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF
Official ID Z-2917-2026 · Official record ↗
Due to off-the-shelf display port component that has audio/video failures
Company / brand: Spacelabs Healthcare
Affected product: Brand Name
Official ID Z-2916-2026 · Official record ↗
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Company / brand: W L Gore & Associates
Affected product: GORE VIABIL Short Wire Biliary Endoprosthesis
Official ID Z-2915-2026 · Official record ↗
10 mm diameter x 7 cm with transmural drainage holes (VSWVH1006) incorrectly labeled as 10 mm diameter x 10 cm length devices without transmural drainage holes (VSWVN1010).
Company / brand: W L Gore & Associates
Affected product: GORE VIABIL Short Wire Biliary Endoprosthesis
Official ID Z-2914-2026 · Official record ↗
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Company / brand: Ventana Medical Systems
Affected product: navify Digital Pathology (on-prem) v2
Official ID Z-2913-2026 · Official record ↗
Due to an increase rate of balloon pinhole defects.
Company / brand: MICROVENTION
Affected product: BOBBY Balloon Guide Catheter REF
Official ID Z-2912-2026 · Official record ↗
Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganism…
Company / brand: Spectra Medical Devices
Affected product: Brand Name
Official ID Z-2873-2026 · Official record ↗
Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
Company / brand: Baxter Healthcare
Affected product: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter
Official ID Z-2766-2026 · Official record ↗
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
Affected product: Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embol
Official ID Z-2911-2026 · Official record ↗
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
Affected product: Blom-Singer Classic Indwelling Voice Prosthesis
Official ID Z-2910-2026 · Official record ↗
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
Affected product: Blom-Singer Classic Indwelling Voice Prosthesis
Official ID Z-2909-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2908-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2907-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2906-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2905-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2904-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2903-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2902-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2901-2026 · Official record ↗
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
Affected product: GEM Premier 5000 PAK Part Numbers
Official ID Z-2900-2026 · Official record ↗
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
Affected product: GEM Premier 7000 with iQM3 Part Numbers
Official ID Z-2899-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2898-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2897-2026 · Official record ↗
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
Affected product: 5-PLASMA Bivalirudin Control
Official ID Z-2896-2026 · Official record ↗
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
Affected product: 5-PLASMA Bivalirudin Calibrator
Official ID Z-2895-2026 · Official record ↗
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
Affected product: 5-PLASMA Bivalirudin AMR Verification Kit
Official ID Z-2894-2026 · Official record ↗
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
Affected product: Philips Allura
Official ID Z-2893-2026 · Official record ↗
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
Affected product: Philips Azurion under the following System Descriptions and corresponding model numbers
Official ID Z-2892-2026 · Official record ↗
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
Affected product: Philips Allura under the following System Descriptions and corresponding model numbers
Official ID Z-2891-2026 · Official record ↗
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
Affected product: Atellica CH Urine Albumin REF
Official ID Z-2890-2026 · Official record ↗
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Company / brand: Beckman Coulter
Affected product: REF # D23354
Official ID Z-2889-2026 · Official record ↗
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Company / brand: Beckman Coulter
Affected product: REF # D23352
Official ID Z-2888-2026 · Official record ↗
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
Affected product: HardyDisk AST Cefiderocol 30¿g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30¿g (FDC30) fo
Official ID Z-2887-2026 · Official record ↗
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic
Affected product: Brand Name
Official ID Z-2886-2026 · Official record ↗
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic
Affected product: Brand Name
Official ID Z-2885-2026 · Official record ↗
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic
Affected product: Brand Name
Official ID Z-2884-2026 · Official record ↗
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
Company / brand: United Orthopedic
Affected product: Brand Name
Official ID Z-2883-2026 · Official record ↗
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
Company / brand: Happiest Baby
Affected product: Happiest Baby
Official ID Z-2882-2026 · Official record ↗
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
Affected product: Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No
Official ID Z-2881-2026 · Official record ↗
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
Affected product: Syva Emit Disopyramide Assay Enzyme Immunoassay
Official ID Z-2880-2026 · Official record ↗
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
Affected product: INFINION CX LEAD KIT
Official ID Z-2879-2026 · Official record ↗
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
Affected product: GE Healthcare Portrait Core Services SW V 1
Official ID Z-2878-2026 · Official record ↗
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
Affected product: FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code
Official ID Z-2877-2026 · Official record ↗
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
Affected product: GE Healthcare MAC VU360
Official ID Z-2876-2026 · Official record ↗
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
Affected product: Merge OrthoPACS
Official ID Z-2875-2026 · Official record ↗
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
Affected product: Merge PACS
Official ID Z-2874-2026 · Official record ↗
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
Affected product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number
Official ID Z-2871-2026 · Official record ↗
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
Affected product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number
Official ID Z-2870-2026 · Official record ↗
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
Affected product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number
Official ID Z-2869-2026 · Official record ↗
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
Affected product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number
Official ID Z-2868-2026 · Official record ↗
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
Affected product: Intramedullary Bone Saw Blade Assembly Model/Catalog Number
Official ID Z-2867-2026 · Official record ↗
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker
Affected product: STRYKER PKG
Official ID Z-2866-2026 · Official record ↗
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker
Affected product: STRYKER PKG
Official ID Z-2865-2026 · Official record ↗
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker
Affected product: STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING
Official ID Z-2864-2026 · Official record ↗
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker
Affected product: STRYKER AHTO TUBE SET WITH TIP PACKAGING
Official ID Z-2863-2026 · Official record ↗
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Company / brand: Stryker
Affected product: STRYKER AHTO TUBE SET PACKAGING
Official ID Z-2862-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2861-2026 · Official record ↗
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
Affected product: Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C2
Official ID Z-2860-2026 · Official record ↗
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
Affected product: Anti-Torque
Official ID Z-2859-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2858-2026 · Official record ↗
Due to a defective circuit board that overheats
Company / brand: Oxos Medical
Affected product: Brand Name
Official ID Z-2857-2026 · Official record ↗
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
Affected product: munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control Application/Smar
Official ID Z-2856-2026 · Official record ↗
Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.
Company / brand: THERANICA BIOELECTRONICS
Affected product: Nerivio Infinity
Official ID Z-2855-2026 · Official record ↗
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
Company / brand: Copan WASP
Affected product: Brand Name
Official ID Z-2854-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2853-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2852-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2851-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2850-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2849-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2848-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2847-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2846-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2845-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2844-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2843-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2842-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2841-2026 · Official record ↗
Potential for breach in sterile barrier of device packaging.
Company / brand: Boston Scientific
Affected product: Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN
Official ID Z-2840-2026 · Official record ↗
Potential for breach in sterile barrier of device packaging.
Company / brand: Boston Scientific
Affected product: Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN
Official ID Z-2839-2026 · Official record ↗
Potential for breach in sterile barrier of device packaging.
Company / brand: Boston Scientific
Affected product: Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN
Official ID Z-2838-2026 · Official record ↗
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Company / brand: INTEGRATED MEDCRAFT
Affected product: Kingfisher Compact Individual First Aid Kit
Official ID Z-2837-2026 · Official record ↗
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Company / brand: INTEGRATED MEDCRAFT
Affected product: FORWARD Oral Airway Kit (OPA Sizes 5
Official ID Z-2836-2026 · Official record ↗
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
Affected product: Charger for the Therabody Theragun
Official ID Z-2835-2026 · Official record ↗
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
Affected product: REMISOL Advance with Software Version 2
Official ID Z-2834-2026 · Official record ↗
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
Affected product: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma
Official ID Z-2798-2026 · Official record ↗
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
Affected product: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma
Official ID Z-2797-2026 · Official record ↗
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
Affected product: Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle Ma
Official ID Z-2796-2026 · Official record ↗
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker
Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 150mm
Official ID Z-2833-2026 · Official record ↗
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker
Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 120mm
Official ID Z-2832-2026 · Official record ↗
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker
Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 90mm
Official ID Z-2831-2026 · Official record ↗
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker
Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 60mm
Official ID Z-2830-2026 · Official record ↗
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker
Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 50mm
Official ID Z-2829-2026 · Official record ↗
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker
Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 40mm
Official ID Z-2828-2026 · Official record ↗
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.
Company / brand: Stryker
Affected product: Stryker Hoffmann II Connecting Rod Micro 3 x 30mm
Official ID Z-2827-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2826-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2825-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2824-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2823-2026 · Official record ↗
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
Affected product: Brand Name
Official ID Z-2822-2026 · Official record ↗
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
Affected product: GEM Premier 5000 with IQM2 Model/Catalog Number
Official ID Z-2821-2026 · Official record ↗
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
Affected product: OsteoBallast
Official ID Z-2820-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2819-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2818-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2817-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2816-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2815-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2814-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2813-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2812-2026 · Official record ↗
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
Affected product: EOPA 3D Arterial Cannula 22FR
Official ID Z-2811-2026 · Official record ↗
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
Affected product: EOPA 3D Arterial Cannula DIL TIP 22FR
Official ID Z-2810-2026 · Official record ↗
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
Affected product: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR
Official ID Z-2809-2026 · Official record ↗
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
Affected product: EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR
Official ID Z-2808-2026 · Official record ↗
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
Affected product: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR
Official ID Z-2807-2026 · Official record ↗
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
Affected product: EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR
Official ID Z-2806-2026 · Official record ↗
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
Affected product: M5 Corpus Power Wheelchair REF
Official ID Z-2805-2026 · Official record ↗
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
Affected product: L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm
Official ID Z-2804-2026 · Official record ↗
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
Affected product: L-Cath PICC S/L Peripherally Inserted Central Catheter
Official ID Z-2803-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2802-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2801-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2800-2026 · Official record ↗
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
Affected product: AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as
Official ID Z-2799-2026 · Official record ↗
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
Affected product: Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF
Official ID Z-2795-2026 · Official record ↗
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
Affected product: Pack Angiography NCMC 3/Cs BANNER
Official ID Z-2792-2026 · Official record ↗
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
Affected product: Power Over Fiber Base Module
Official ID Z-2745-2026 · Official record ↗
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
Affected product: Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous
Official ID Z-2735-2026 · Official record ↗
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
Affected product: Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity
Official ID Z-2652-2026 · Official record ↗
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
Affected product: IQon Spectral CT IQon Spectral CT Upgrades
Official ID Z-2651-2026 · Official record ↗
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
Affected product: Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 B
Official ID Z-2650-2026 · Official record ↗
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
Affected product: Flexible Hystero-Fiberscope Kits REF
Official ID Z-2794-2026 · Official record ↗
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
Affected product: SafeOp Patient Interface
Official ID Z-2793-2026 · Official record ↗
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
Affected product: Medline medical convenience kits labeled as
Official ID Z-2791-2026 · Official record ↗
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
Affected product: Medline medical convenience kits labeled as
Official ID Z-2790-2026 · Official record ↗
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
Affected product: Medline medical convenience kits labeled as
Official ID Z-2789-2026 · Official record ↗
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
Affected product: Medline medical convenience kits labeled as
Official ID Z-2788-2026 · Official record ↗
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
Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16
Official ID Z-2787-2026 · Official record ↗
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
Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16
Official ID Z-2786-2026 · Official record ↗
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
Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16
Official ID Z-2785-2026 · Official record ↗
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
Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16
Official ID Z-2784-2026 · Official record ↗
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
Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16
Official ID Z-2783-2026 · Official record ↗
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
Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16
Official ID Z-2782-2026 · Official record ↗
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
Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16
Official ID Z-2781-2026 · Official record ↗
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
Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16
Official ID Z-2780-2026 · Official record ↗
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
Affected product: Medline convenience kits containing Bard¿ Silastic¿ Foley Catheters (French sizes 16
Official ID Z-2779-2026 · Official record ↗
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
Affected product: MiniMed Go App
Official ID Z-2778-2026 · Official record ↗
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
Affected product: Emano Flow with software version v2
Official ID Z-2777-2026 · Official record ↗
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Company / brand: Olympus of the Americas
Affected product: Olympus High Flow Insufflation Unit - UHI-4
Official ID Z-2776-2026 · Official record ↗
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
Affected product: SnapshotGLO Wound Imaging Device
Official ID Z-2775-2026 · Official record ↗
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
Affected product: Pipeline Flex Embolization Device with Shield Technology
Official ID Z-2774-2026 · Official record ↗
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
Affected product: Pipeline Flex Embolization Device with Shield Technology
Official ID Z-2773-2026 · Official record ↗
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
Affected product: Halyard STANDARD LINE INSERTION PACK
Official ID Z-2772-2026 · Official record ↗
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
Affected product: Boston Scientific TheraSphere 360 Y-90 Management Platform
Official ID Z-2771-2026 · Official record ↗
Due to manufacturing issues, reperfusion catheters may fractures
Company / brand: Penumbra
Affected product: Penumbra System RED 68 Reperfusion Catheter REF
Official ID Z-2770-2026 · Official record ↗
Due to device not having FDA Clearance
Company / brand: Prismatik Dentalcraft
Affected product: Brand Name
Official ID Z-2769-2026 · Official record ↗
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
Affected product: Ventriculostomy Kit
Official ID Z-2768-2026 · Official record ↗
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
Affected product: 3mensio Workstation (Vascular Fenestrated) software
Official ID Z-2767-2026 · Official record ↗
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
Affected product: MEDLINE medical procedure convenience kit labeled as
Official ID Z-2765-2026 · Official record ↗
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
Affected product: MEDLINE medical procedure convenience kit labeled as
Official ID Z-2764-2026 · Official record ↗
Incorrect concentration of Betadine solution contained within certain AVID convenience kits.
Company / brand: AVID Medical
Affected product: Halyard EYE PACK
Official ID Z-2763-2026 · Official record ↗
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Company / brand: SEASPINE ORTHOPEDICS
Affected product: SeaSpine Polyaxial Head REF Number
Official ID Z-2762-2026 · Official record ↗
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Company / brand: Olympus of the Americas
Affected product: Olympus 4K UHD LCD Monitor
Official ID Z-2761-2026 · Official record ↗
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
Affected product: Power F2 Powered Fastening System
Official ID Z-2760-2026 · Official record ↗
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
Affected product: Hotline Fluid Warming Set
Official ID Z-2759-2026 · Official record ↗
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Company / brand: Paragon 28
Affected product: P28 PHANTON INTRAMEDULLARY NAIL SYSTEM
Official ID Z-2758-2026 · Official record ↗
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
Affected product: FARADRIVE STEERABLE SHEATH CLEAR OUS
Official ID Z-2757-2026 · Official record ↗
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
Affected product: FARADRIVE STEERABLE SHEATH (CLEAR) - US
Official ID Z-2756-2026 · Official record ↗
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
Affected product: FARADRIVE STEERABLE SHEATH CLEAR
Official ID Z-2755-2026 · Official record ↗
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
Affected product: FARADRIVE Steerable Sheath Clear IDE
Official ID Z-2754-2026 · Official record ↗
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
Affected product: FARASTAR Ablation Generator EU
Official ID Z-2753-2026 · Official record ↗
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Company / brand: Boston Scientific
Affected product: FARASTAR PFA Generator
Official ID Z-2752-2026 · Official record ↗
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Sources last checked September 7, 2026 at 6:00 AM UTC.