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Browse Device Recalls

2 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2 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 2 FDA device recalls.

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DateProductReasonClassFirm
Oct 31, 2023 The 4Kscore Test, an in vitro serum or plasma test that combines the results ... Mathematical modeling of the 4Kscore with and without DRE information was recently performed on o... Class II BioReference Health, LLC
Nov 18, 2022 The 4Kscore Test is an in vitro serum or plasma test that combines the result... SPM software anomalies that may lead to the generation of erroneous 4Kscore Test results Class II BioReference Health, 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.