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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Feb 6, 2026 Owner's Booklets and Instructions for Use that are used with the following bl... The system labeling (user manual and online labeling) did not provide adequate directions for lay... Class I Trividia Health, Inc.
Oct 7, 2025 Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Mode... Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that ... Class II Trividia Health, Inc.
Apr 20, 2020 TRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended... One (1) TRUE METRIX AIR blood glucose meter distributed in the United States was packaged into a ... Class II Trividia Health, 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.