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Browse Device Recalls

262 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 262 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 262 FDA device recalls.

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DateProductReasonClassFirm
Jan 6, 2016 Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject set... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Jan 6, 2016 Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays... A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse e... Class I Cook Inc.
Nov 19, 2015 VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access an... Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricul... Class II Cook Inc.
Oct 21, 2015 Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight c... Cook Medical has received six product complaints associated with reports of the 2.6FR curved cath... Class II Cook Inc.
Oct 7, 2015 Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angi... Reports of catheter tip splits and or separation. Loss of device function, medical intervention t... Class I Cook Inc.
Jul 2, 2015 Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use i... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jul 2, 2015 Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiog... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
Jul 2, 2015 Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. ... Reports of catheter tip splits and or separation. Loss of device function, medical intervention ... Class I Cook Inc.
May 28, 2015 Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths... Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and t... Class II Cook Inc.
May 28, 2015 Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transju... Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and t... Class II Cook Inc.
May 14, 2015 LapSac Surgical Tissue Pouch. The current intended use for the LapSac Sur... Includes Information not stated in the intended use. Class II Cook Inc.
Jul 17, 2014 CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-... This remedial action is the result of six product complaints associated with separation of the sn... Class I Cook 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.