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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Aug 13, 2020 Clinical Innovations ROM Plus Collection Kit IFU: ROM Plus Rupture of Mem... Possible false negative or false positive results. The incorrect sample collection swabs (non-sc... Class II Clinical Innovations, LLC
Aug 6, 2019 Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: ... There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal... Class II Clinical Innovations, LLC
May 30, 2019 Clearview Total Uterine Manipulator (model UM750), The device is labeled in ... An incorrect component used during manufacturing. The uterine manipulator tip support does not ha... Class II Clinical Innovations, LLC
Jan 5, 2015 The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended f... Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) L... Class II Clinical Innovations, LLC
Dec 30, 2014 Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx On... Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014. Class II Clinical Innovations, 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.