FDA Not Yet Classified · Drug · August 19, 2026
Cefazolin in Dextrose recall — Baxter Healthcare Corporation
Presence of Particulate Matter
Company / brand: Baxter Healthcare
Official ID EVT-99463-1krekt6 · Official record ↗
FDA recalls
1,936 recent recalls from the U.S. Food & Drug Administration in our current data (last 90 days). Showing the 300 most recent — use the search box above to find a specific product.
FDA Not Yet Classified · Food · August 19, 2026
MARKON BLEND LETT/ROM 80/20 WITH SEP BAGGIES 4/5# Iceberg recall — Taylor Farms de Mexico S. de R.L. de C.V.
Potential Cyclospora contamination.
Company / brand: Taylor Farms de Mexico S. de R.L. de C.V
Official ID EVT-99453-wgl5uq · Official record ↗
FDA Class II · Medical device · August 19, 2026
Cardinal Health Presource Kits recall — Cardinal Health 200, LLC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Official ID Z-2949-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Cardinal Health Presource Kits recall — Cardinal Health 200, LLC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Official ID Z-2948-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Cardinal Health Presource Kits recall — Cardinal Health 200, LLC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Official ID Z-2947-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Cardinal Health Presource Kits recall — Cardinal Health 200, LLC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Official ID Z-2946-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Cardinal Health Presource Kits recall — Cardinal Health 200, LLC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Official ID Z-2945-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Cardinal Health Presource Kits recall — Cardinal Health 200, LLC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Official ID Z-2944-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Cardinal Health Presource Kits recall — Cardinal Health 200, LLC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Official ID Z-2943-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Cardinal Health Presource Kits recall — Cardinal Health 200, LLC
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Company / brand: Cardinal Health 200
Official ID Z-2942-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code recall — BD SWITZERLAND SARL
Products may not have received adequate sterilization processing.
Company / brand: BD SWITZERLAND SARL
Official ID Z-2941-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number recall — Erbe USA Inc
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
Official ID Z-2938-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
ProNephro AKI (NGAL) Reagent Kit (100 tests) recall — Bioporto Diagnostics A/S
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
Official ID Z-2937-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
BIOFIRE Respiratory Panel 2 recall — BioFire Diagnostics, LLC
Due to increase in false negative results
Company / brand: BioFire Diagnostics
Official ID Z-2936-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Straumann Bone Level Tapered (BLT) Implant recall — Straumann USA LLC
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
Official ID Z-2935-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Endo-Model recall — Waldemar Link GmbH & Co. KG (Mfg Site)
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)
Official ID Z-2934-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
OBP Medical recall — OBP Medical Corporation
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
Official ID Z-2933-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Philips Azurion recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
Official ID Z-2932-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Philips Azurion Rystem recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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
Official ID Z-2931-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
GLIDESHEATH SLENDER A-KIT 6F 10CM recall — Terumo Medical Corporation
Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
Company / brand: Terumo Medical
Official ID Z-2930-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
GM Helix Implant recall — Straumann USA LLC
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
Official ID Z-2929-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Allura Xper FD recall — PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Firmware issue potentially leading to loss of geometry movements.
Company / brand: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V
Official ID Z-2928-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL recall — Remel Europe Ltd.
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
Official ID Z-2927-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes recall — Medline Industries, LP
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
Official ID Z-2926-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes recall — Medline Industries, LP
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
Official ID Z-2925-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes recall — Medline Industries, LP
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
Official ID Z-2924-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes recall — Medline Industries, LP
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
Official ID Z-2923-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX recall — Covidien, LP
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
Official ID Z-2922-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 recall — Covidien, LP
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
Official ID Z-2921-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU recall — Covidien, LP
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
Official ID Z-2920-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY P recall — Covidien, LP
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
Official ID Z-2919-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22 G recall — Covidien, LP
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
Official ID Z-2918-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF recall — Galt Medical Corporation
Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of transcarotid-peripheral access kits.
Company / brand: Galt Medical
Official ID Z-2917-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
Brand Name recall — Spacelabs Healthcare, Inc.
Due to off-the-shelf display port component that has audio/video failures
Company / brand: Spacelabs Healthcare
Official ID Z-2916-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
GORE VIABIL Short Wire Biliary Endoprosthesis recall — W L Gore & Associates, Inc.
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
Official ID Z-2915-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
GORE VIABIL Short Wire Biliary Endoprosthesis recall — W L Gore & Associates, Inc.
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
Official ID Z-2914-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
navify Digital Pathology (on-prem) v2 recall — Ventana Medical Systems, Inc.
Due to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window
Company / brand: Ventana Medical Systems
Official ID Z-2913-2026 · Official record ↗
FDA Class II · Medical device · August 19, 2026
BOBBY Balloon Guide Catheter REF recall — MICROVENTION INC.
Due to an increase rate of balloon pinhole defects.
Company / brand: MICROVENTION
Official ID Z-2912-2026 · Official record ↗
FDA Class I · Medical device · August 19, 2026
Brand Name recall — Spectra Medical Devices, Llc
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
Official ID Z-2873-2026 · Official record ↗
FDA Class I · Medical device · August 19, 2026
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recall — Baxter Healthcare Corporation
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
Official ID Z-2766-2026 · Official record ↗
FDA Class I · Food · August 19, 2026
Grade A White In-shell Chicken eggs packaged in the following configurations recall — MIDWEST POULTRY SERVC C/O H & LELECTRIC
Possible Salmonella Enteritidis
Company / brand: MIDWEST POULTRY SERVC C/O H & LELECTRIC
Official ID H-1230-2026 · Official record ↗
FDA Class I · Food · August 19, 2026
Grade A Brown In-shell Chicken eggs packaged in the following configurations recall — MIDWEST POULTRY SERVC C/O H & LELECTRIC
Possible Salmonella Enteritidis
Company / brand: MIDWEST POULTRY SERVC C/O H & LELECTRIC
Official ID H-1229-2026 · Official record ↗
FDA Class I · Food · August 19, 2026
Dark Chocolate Coconut Almond Bites recall — Bazzini LLC
Undeclared peanuts
Company / brand: Bazzini
Official ID H-1228-2026 · Official record ↗
FDA Class III · Food · August 19, 2026
Honeyville YELLOW COLOR 1 GALLON NFI recall — FlavorsandColor.Com
Undeclared Red #40.
Company / brand: FlavorsandColor.Com
Official ID H-1225-2026 · Official record ↗
FDA Class II · Food · August 19, 2026
Vodka Tomato Sauce recall — SHEANDRO LLC
Label declares cream and cheese, but Milk is not declared
Company / brand: SHEANDRO
Official ID H-1224-2026 · Official record ↗
FDA Class I · Drug · August 19, 2026
Optiray Imaging Bulk Package-350 recall — Liebel-Flarsheim Company LLC
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
Company / brand: Liebel-Flarsheim Company
Official ID D-0773-2026 · Official record ↗
FDA Class I · Drug · August 19, 2026
Glutathione (MDV) recall — Victory Medical Center Pharmacy
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
Company / brand: Victory Medical Center Pharmacy
Official ID D-0772-2026 · Official record ↗
FDA Class I · Drug · August 19, 2026
Kian Pee Wan Capsules recall — Buy-Herbal
Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
Company / brand: Buy-Herbal
Official ID D-0769-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION recall — Heritage Pharmaceuticals Inc
Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Company / brand: Heritage Pharmaceuticals
Official ID D-0768-2026 · Official record ↗
FDA Class II · Drug · August 19, 2026
CLEAR EYES Maximum Itchy Eye Relief recall — Prestige Brands Holdings
Lack of assurance of sterility. The recall is due to potential contamination
Company / brand: Prestige Brands Holdings
Official ID D-0766-2026 · Official record ↗
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
Official ID D-0763-2026 · Official record ↗
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
Official ID D-0762-2026 · Official record ↗
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
Official ID D-0761-2026 · Official record ↗
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
Official ID D-0760-2026 · Official record ↗
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Official ID Z-2796-2026 · Official record ↗
FDA Class I · Food · August 12, 2026
KC Everyday Mac & Cheese recall — Kerry, Inc
Undeclared allergen (egg)
Company / brand: Kerry
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Official ID D-0742-2026 · 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 September 7, 2026 at 6:00 AM UTC.