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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
Oct 17, 2022 Accelerate PhenoTest BC kit REF 10102018 Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) prob... Class II Accelerate Diagnostics Inc
Oct 17, 2022 Accelerate PhenoTest BC kit REF 10101018 Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) prob... Class II Accelerate Diagnostics Inc
Mar 14, 2018 Accelerate PhenoTest BC kit, Ref #10101018. The firm name on the label is Ac... The kits may produce an elevated rate of false positive calls for the Staphylococcus aureus ident... Class II Accelerate Diagnostics Inc
Mar 13, 2017 Accelerate Pheno system, with Accelerate Pheno System Software 1.2.1 - 1.3.1,... Rare isolates of Enterobacteriaceae may generate a susceptible meropenem Minimum Inhibitory Conce... Class II Accelerate Diagnostics 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.