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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
Jul 4, 2014 AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro ... Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, f... Class II Advandx Inc
Sep 14, 2012 AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identific... Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P... Class II Advandx Inc
Sep 14, 2012 AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identific... GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomona... Class II Advandx 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.