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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
Feb 5, 2025 MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (... Entering multiple keys that trigger input simultaneously may remove data from first field of scre... Class II Medical Information Technology, Inc.
Feb 21, 2014 MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.0... Potential for erroneous result reporting. Class II Medical Information Technology, Inc.
Jan 17, 2014 MEDITECH Microbiology - Calculator/data processing module, for clinical use. Potential for patient results being removed from LAB/EMR. Class II Medical Information Technology, Inc.
May 7, 2013 MEDITECH Bi-Directional interactive Communication Analyzer Interface; Int... Incorrect transmission of laboratory results. Class II Medical Information Technology, 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.