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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
Sep 13, 2016 ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US,... Customers complained of low/empty reagent vials. Class II TEM Systems Inc
Feb 18, 2016 ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diag... Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA i... Class II TEM Systems Inc
Oct 23, 2014 ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for:... Some of vials were found to be partially filled. Class II TEM Systems 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.