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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Apr 9, 2025 FoundationOne Companion Diagnostic (F1CDx) Four (4) total reports were sent to customers with clinically relevant variants requiring amendme... Class II Foundation Medicine, Inc.
Jun 18, 2024 FoundationOne Companion Diagnostic (F1CDx) Two (2) reports were sent to customers with an incorrect negative claim on the claims page; the d... Class II Foundation Medicine, Inc.
Feb 15, 2023 FoundationOne Companion Diagnostic (F1CDx) An incorrect negative claim was identified on the claims page; the device variant information was... Class II Foundation Medicine, Inc.
Nov 8, 2022 FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0 Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... Class II Foundation Medicine, Inc.
Nov 8, 2022 FoundationOne CDx (F1CDx), RAL-0003 version 31.0 Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages ... Class II Foundation Medicine, Inc.
Aug 8, 2019 FoundationOne CDx test report Identified potential false positive MSI-H on the test reports provided to the physicians. Class II Foundation Medicine, Inc.
Oct 31, 2018 FoundationOne CDx Test Results An incorrect test result for a single analyte may have been reported for up to 800 physician reports Class II Foundation Medicine, 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.