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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Jul 17, 2024 PE Centrifuge, REF: B36365, a component of the Power Express The adhesive joint between the plastic socket and metal component of the Power Express Sample Hol... Class II Beckman Coulter Biomedical GmbH
Jul 17, 2024 Power Express, REF B90918 The adhesive joint between the plastic socket and metal component of the Power Express Sample Hol... Class II Beckman Coulter Biomedical GmbH
Jul 17, 2024 PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power E... The adhesive joint between the plastic socket and metal component of the Power Express Sample Hol... Class II Beckman Coulter Biomedical GmbH
Jun 2, 2023 Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 1... A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... Class II Beckman Coulter Biomedical GmbH
Jun 2, 2023 Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240... A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... Class II Beckman Coulter Biomedical GmbH
Jun 17, 2020 DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA ... The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman C... Class II Beckman Coulter Biomedical GmbH
May 24, 2018 Software Package, iPAW 4.2.1 User Kit for Windows XP and Windows 10, Part No.... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... Class III Beckman Coulter Inc.
May 24, 2018 Software Package, Sorting-Drive 4.2.1 User Kit for Windows XP and Windows 10... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... Class III Beckman Coulter Inc.
May 24, 2018 Software Package, iPAW 4.2 User Kit, Part No. B73489, Manufactured by: Beckma... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option for iPAW an... Class III Beckman Coulter Inc.
May 24, 2018 Software Package, Sorting-Drive 4.2 User Kit, Part No. B73488, Manufactured b... Sorting-Drive software version 4.2 (released in October 2015) introduced a new option which inclu... Class III Beckman Coulter 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.