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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Apr 29, 2014 Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 ... Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition,... Class I Convatec Inc.
Feb 7, 2014 Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Pr... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 7, 2014 Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD1191... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 7, 2014 SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Us... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 7, 2014 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: L... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 7, 2014 SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Late... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Feb 7, 2014 JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Fol... The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coat... Class II Convatec Inc.
Jun 25, 2013 ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage:... ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... Class III Convatec Inc.
Jun 25, 2013 ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage f... ConvaTec notified their customers on 6/25/2013 regarding the manufacturing irregularity that occu... Class III Convatec 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.