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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
Jul 7, 2022 AIM-V Medium REF AV.200/500 Due to equipment failure, affected products were stored at temperatures outside the validated ran... Class II OXFORD IMMUNOTEC LTD
Jul 7, 2022 T-SPOT.TB REF TB.300 US Due to equipment failure, affected products were stored at temperatures outside the validated ran... Class II OXFORD IMMUNOTEC LTD
Jul 7, 2022 T-Cell Xtend REF TTK.610 US Due to equipment failure, affected products were stored at temperatures outside the validated ran... Class II OXFORD IMMUNOTEC LTD
Jul 16, 2020 Model No:T-SPOT.TB50, Catalogue No.: TB.50; UDI: 1505171600004 - Product Usag... Incorrect expiration date included in test kit labeling and/or in Substrate component label. Class III Oxford Immunotec
Jul 16, 2020 Model No:T-SPOT.TB8, Catalogue No.: TB.300; UDI: 1505171600030 - Product Usag... Incorrect expiration date included in test kit labeling and/or in Substrate component label. Class III Oxford Immunotec

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.