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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
May 15, 2015 Cell Search Circulating Tumor Kit. Intended for the enumeration of circulatin... Complaints of the presence of artifacts that appears as small bead like structures in the image g... Class II Veridex, LLC
Jan 8, 2014 CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRAC... Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿. Class II Veridex, LLC
Dec 28, 2012 CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: ... Veridex, LLC has received a report that a patient's demographics were incorrectly associated with... Class II Veridex, LLC
Dec 28, 2012 CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usag... Veridex, LLC has received a report that a patient's demographics were incorrectly associated with... Class II Veridex, LLC

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.