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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
Oct 6, 2025 OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materi... A labeling error was identified on the affected product. The expiration date on the kit box label... Class III POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC P...
Apr 30, 2018 PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a pro... A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... Class II Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr...
Apr 30, 2018 PATHFAST Myoglobin II reagent cartridge Catalog Number: PF1111-K PATHFAST... A pinhole caused by the laser printer in the aluminum sheet over the ALP reagent wells caused lea... Class II Polymedco, Inc.,/Polymedco Cancer Diagnostic Pr...
Feb 12, 2013 Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOB50. ... The test strips in the affected product lots of the OC Light immunological fecal occult blood tes... Class II Polymedco, Inc
Feb 12, 2013 Test Strips packaged in the OC-Light Manual iFOBT Kit, Catalog No. FOBSTR. ... The test strips in the affected product lots of the OC Light immunological fecal occult blood tes... Class II Polymedco, 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.