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Browse Device Recalls

55 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 55 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 55 FDA device recalls.

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DateProductReasonClassFirm
Oct 7, 2014 Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone baske... The product is non-sterile. Class II C.R. Bard, Inc.
Jun 10, 2013 StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single U... BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices... Class II Bard Access Systems
Jan 23, 2013 MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide;... Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... Class II Bard Peripheral Vascular Inc
Sep 7, 2012 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The p... The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (... Class II C.R. Bard, Inc., Urological Division
Jun 29, 2012 Bard Foley procedural trays packaged in breather bags. The product is packag... Incomplete seal on sterile packages of product. Class II C.R. Bard, Inc., Urological Division

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.