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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Apr 15, 2016 VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated qu... Due to a packaging error; The kit does not contain the correct number of C1 or C2 control vials. Class III Biomerieux France Chemin De L'Or
Nov 8, 2013 ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reve... bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leadin... Class II Biomerieux France Chemin De L'Or
Nov 8, 2013 API Listeria (REF 10300) API Listeria is a standardized system for the ide... bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leadin... Class II Biomerieux France Chemin De L'Or
Nov 8, 2013 API NH (REF 10400) API NH is a standardized system for the identification ... bioM¿rieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leadin... Class II Biomerieux France Chemin De L'Or

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.