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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Dec 10, 2021 THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA This recall was initiated to recover a Dunnage Case, which is a case of three (3) CLXUSA kits. Th... Class II Mallinckrodt Pharmaceuticals Ireland Ltd
Oct 4, 2021 THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA Product was released prior to all testing being completed. If used and a drive tube leak were to ... Class II Therakos, Inc.
Mar 1, 2021 Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "... The kit does not have an emergency use authorization (EUA). Class II Cellex
Dec 21, 2015 The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CL... The Mallinckrodt (Therakos) post-market monitoring process detected an increased trend in tubing ... Class II Therakos 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.