Recalls published in November 2025
Everything the FDA, USDA FSIS, CPSC and NHTSA announced in November 2025, newest first.
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
B-K Medical A/S 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814 recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Total Joint Orthopedics, Inc. Brand Name: Klassic BiPolar Head Model/ recall: Potential packaging issue that could compromise the sterile barrier. Defect
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk…
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Class II · 12 months ago
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene recall: Zimmer Biomet is conducting a medical device recall for two (2) lots
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is…
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Class II · 12 months ago
Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS recall: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be…
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Class II · 12 months ago
B-K Medical A/S UUltrasound System 2300, bkActiv w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260 recall: An internal investigation has determined that due to defective sub-components
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
B-K Medical A/S bk5000 Ultrasound System w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene recall: Zimmer Biomet is conducting a medical device recall for two (2) lots
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is…
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Class II · 12 months ago
Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS recall: Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction
Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be…
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Class II · 12 months ago
B-K Medical A/S Ultrasound System 1300, bkSpecto w/battery recall: GE HealthCare has become aware that the Instructions for Use within the user
GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class I · 12 months ago
Integra LifeSciences Corp. Codman Disposable Perforator 11mm. Cranial Perforator recall: Expansion of recall of size 14 mm Codman Disposable Perforators
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an…
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Class II · 12 months ago
Mozarc Medical US LLC Mahurkar" Acute High Pressure Triple Lumen Catheter Tray Curved recall: A potential issue with the seal integrity of header bag packaging
A potential issue with the seal integrity of header bag packaging.
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Class II · 12 months ago
Prismatik Dentalcraft, Inc. Brand Name: Inclusive Product Name: Inclusive Titanium recall: Incorrect titanium screw, packaged with dental implant
Incorrect titanium screw, packaged with dental implant.
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 75 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 50 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Zydus Pharmaceuticals Inc clomiPramine Hydrochloride, Capsules, USP, 25 mg recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above…
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Class II · 12 months ago
Aero Healthcare Acetaminophen 500mg Caffeine 65mg caplets recall: Labeling: Label Mix-up. This issue affects the outer box labeling only
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine…
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Class II · 12 months ago
Teva Pharmaceuticals USA, Inc Amoxicillin and Clavulanate Potassium for Oral recall: Subpotent drug; Clavulanate Potassium component
Subpotent drug; Clavulanate Potassium component
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Class II · 12 months ago
AquaStar Corp. Best Yet Frozen Raw EZ-Peel White Shrimp 16/20 recall: Shrimp may be contaminated with Cesium-137 (Cs-137)
Shrimp may be contaminated with Cesium-137 (Cs-137).
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Class I · 12 months ago
Big Y Brown Jumbo A 12ct Eggs recall: Firm received, repackaged eggs that are potentially contamination
Firm received, repackaged eggs that are potentially contamination with Salmonella.
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Class II · 12 months ago
Strawberry Cheesecake Ice Cream with graham crackers swirl recall: Foreign material fragments consisting of aluminum foil and packaging material
Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in…