Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 7 FDA device recalls.

Clear
DateProductReasonClassFirm
Feb 1, 2023 BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein... New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein... Class II Aniara Diagnostica LLC
Jun 28, 2022 BIOPHEN UFH Control Plasma Incorrect product labeling was included in the package. Class III Aniara Diagnostica LLC
Jul 19, 2019 ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagn... Residual crystallization of the microplate and recurrent negative controls out of range. Class II Aniara Diagnostica LLC
Jul 19, 2019 ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnos... Residual crystallization of the microplate and recurrent negative controls out of range. Class II Aniara Diagnostica LLC
Mar 19, 2019 BIOPHEN UFH Control C2, REF 223901 The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t... Class III Aniara Diagnostica LLC
Mar 19, 2019 BIOPHEN LMWH Control C4, REF 224201 The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t... Class III Aniara Diagnostica LLC
Mar 19, 2019 BIOPHEN UFH Control C1, REF 224101 The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for t... Class III Aniara Diagnostica LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.