Browse Device Recalls

681 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 681 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 681 FDA device recalls.

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Date	Product	Reason	Class	Firm
Dec 18, 2013	Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Inject...	Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo...	Class II	Boston Scientific Corporation
Dec 18, 2013	Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injec...	Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo...	Class II	Boston Scientific Corporation
Dec 18, 2013	Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects...	Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloo...	Class II	Boston Scientific Corporation
Nov 20, 2013	TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration) Univ...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration) Unive...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration) Univ...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration) Unive...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration) Inte...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 20, 2013	TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration) Univ...	Sterility of device may be compromised due to lack of pouch seal integrity	Class II	Boston Scientific Corporation
Nov 5, 2013	Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M00625022...	The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ...	Class II	Boston Scientific Corporation
Nov 5, 2013	Navigator HD l3F/15F x 36cm Ureteral Access Sheath Set Product No M006250228...	The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ...	Class II	Boston Scientific Corporation
Nov 5, 2013	Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M006250228...	The 13F/15F Navigator HD Ureteral Access SheathSet are being recalled after receipt of 5 reports ...	Class II	Boston Scientific Corporation
Aug 29, 2013	Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat...	The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact...	Class II	Boston Scientific CRM Corp
Aug 29, 2013	Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11...	The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact...	Class II	Boston Scientific CRM Corp
Jul 31, 2013	Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiatio...	Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut...	Class II	Boston Scientific Corporation
Jul 31, 2013	Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irrad...	Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut...	Class II	Boston Scientific Corporation
Jul 15, 2013	Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable C...	Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to...	Class II	Boston Scientific CRM Corp
Jun 24, 2013	Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Cat...	The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner...	Class II	Stryker Neurovascular
May 28, 2013	NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog...	Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Ca...	Class II	Boston Scientific Corporation
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
Apr 10, 2013	LATITUDE¿ Patient Management System, Model 6488, Version 7.3. The LATITUDE...	Boston Scientific CRM is conducting a recall on the LATITUDE Patient Management System Model 6488...	Class II	Boston Scientific CRM Corp
Mar 1, 2013	Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generato...	An internal protective fuse can be unintentionally activated while the device is charging its cap...	Class II	Boston Scientific CRM Corp
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.