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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Apr 4, 2017 "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitatio... Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Pro... Class II Helena Laboratories, Inc.
Feb 24, 2017 Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at ... Due to some cards in this lot reported to have experienced variations in results, (verified by wa... Class II Helena Laboratories, Inc.
Nov 7, 2016 Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase I... Due to a customer experiencing complaints on bone fraction of assay not being in range. The co... Class III Helena Laboratories, Inc.
Oct 14, 2016 Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL Due to customer-experienced complaints on narrow assay range compared to prior lots and the user ... Class II Helena Laboratories, Inc.
Apr 20, 2016 Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at ... Due to some cards in this lot experiencing variations in wave form, resulting in some cards with ... Class II Helena Laboratories, Inc.

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.