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Browse Device Recalls

610 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 610 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 610 FDA device recalls.

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DateProductReasonClassFirm
May 28, 2013 Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Materia... Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch o... Class II Boston Scientific Corporation
May 28, 2013 NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Ca... Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca... Class II Boston Scientific Corporation
May 28, 2013 RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00... Product labeled with incorrect expiration date. Class III Boston Scientific Corporation
Sep 17, 2012 Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15). Disposable, mono... Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... Class II Boston Scientific Corporation
Sep 17, 2012 LeVeen Standard Needle Electrode System, Sterile (3.5/12), (3.5/15), (4.0/15)... Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... Class II Boston Scientific Corporation
Sep 17, 2012 Leveen Coaccess Introducer Set. Disposable, monopolar, electrosurgical dev... Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portugue... Class II Boston Scientific Corporation
Sep 6, 2012 Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distri... During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardia... Class II Greatbatch Medical
May 16, 2012 Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00... Difficulty in extending snare loop from the catheter Class II Boston Scientific Corporation
May 16, 2012 Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M005... Difficulty in extending snare loop from the catheter Class II Boston Scientific Corporation
May 16, 2012 Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00... Difficulty in extending snare loop from the catheter Class II Boston Scientific Corporation

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.