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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
Jun 20, 2014 Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro ... Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non... Class II ITC-Nexus Dx
Dec 19, 2013 Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulati... ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in n... Class II ITC-Nexus Dx
Aug 22, 2013 Surgicutt fully automated incision making device for bleeding time determinat... ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; L... Class II ITC-Nexus Dx

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.