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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Oct 5, 2021 Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-00... The Control Level I material value was showing results exceeding the upper limit of the acceptabl... Class III Primus Corporation dba Trinity Biotech
Oct 5, 2021 A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Con... The Control Level I material value was showing results exceeding the upper limit of the acceptabl... Class III Primus Corporation dba Trinity Biotech
Oct 9, 2020 Ultra2 Resolution Variants System for Abnormal Hemoglobin Quantitation The product did not receive pre-market approval or clearance. Class II Primus Corporation

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.