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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Feb 4, 2019 US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock... Potential esophageal laceration during a patient procedure Class II US Endoscopy Group Inc
Dec 13, 2016 Roth Net Polyp Retrieval The firm was notified that the expiration date on the outer carton is different than the expirati... Class III US Endoscopy Group Inc
May 18, 2016 Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 ... US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needl... Class II US Endoscopy Group Inc
Jul 14, 2015 Histolock Resection Device, US Endoscopy. An electrosurgical device desig... The company has determined the sterility cannot be assured for the affected lot. Class II US Endoscopy Group Inc
Mar 10, 2015 Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign b... A wire component on the distal grasping assembly of the device became detached.. Class II US Endoscopy Group Inc
Feb 17, 2015 Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable ... The company has received reports of structural non conformance at the connection between the valv... Class II US Endoscopy Group Inc
Oct 31, 2014 UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary p... Packaging non-conformance related to the integrity of the sterile pouch seal. Class II US Endoscopy Group Inc
Mar 7, 2013 Torrent" irrigation tubing. Product Usage: The Torrent irrigation sys... The firm was notified by their customers that there was a water leakage from the white tubing con... Class II US Endoscopy Group Inc
Dec 22, 2011 Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc... US Endoscopy received five complaints which noted difficulty in deploying the cytology brush thro... Class II US Endoscopy Group Inc
Nov 14, 2011 Endoscopic retrieval device. The disposable Raptor grasping device in inte... When the outer catheter is either coiled or in a contorted configuration outside of the endoscope... Class II US Endoscopy Group 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.