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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
Aug 23, 2024 Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of h... This recall was initiated due to customer complaints of false negative of hCG test results when r... Class II Princeton Biomeditech Corp
Mar 9, 2012 Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc B... There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class II Princeton Biomeditech Corp
Mar 9, 2012 Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation ... There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class II Princeton Biomeditech Corp
Mar 9, 2012 Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Roa... There have been reports of dual positive (Flu A + Flu B positive) results being encountered. Class II Princeton Biomeditech Corp

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.