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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
Apr 1, 2022 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Point of Care (PoC) rapid test products were distributed to customers who did not have a valid CL... Class I CELLTRION USA INC
Feb 25, 2022 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Kits were labeled with incorrect expiration dates. Class II CELLTRION USA INC
Dec 28, 2021 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 The affected lot was placed under quarantine in September 2021 due to complaints of alleged false... Class I CELLTRION USA INC
Dec 2, 2021 Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02 Returned test kits were erroneously shipped to customers. The kits are intended for Research Use ... Class I CELLTRION USA INC
Dec 1, 2021 Celltrion DiaTrust COVID-19 Ag Rapid Test, REF CT-P60 D-2 01. Contains 25 dis... The European version of the DiaTrust COVID-19 Ag Rapid Test is not approved for marketing in the ... Class II CELLTRION USA 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.