Browse Device Recalls

603 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 603 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 603 FDA device recalls.

Clear

Date	Product	Reason	Class	Firm
Dec 22, 2021	JAGTOME RX 39-20-450-025 Material Number: M00573090	Sterility of device is compromised due to a sterile barrier breach	Class II	Boston Scientific Corporation
Dec 22, 2021	JAGTOME RX 39-30-260-025 Material Number: M00573100	Sterility of device is compromised due to a sterile barrier breach	Class II	Boston Scientific Corporation
Dec 22, 2021	DREAMTOME 44-30MM/260CM Material Number: M00584050	Sterility of device is compromised due to a sterile barrier breach	Class II	Boston Scientific Corporation
Dec 22, 2021	HYDRATOME RX 49-20MM/260CM Material Number: M00583000	Sterility of device is compromised due to a sterile barrier breach	Class II	Boston Scientific Corporation
Dec 22, 2021	JAGTOME RX 44-20-260-035 Material Number: M00573040	Sterility of device is compromised due to a sterile barrier breach	Class II	Boston Scientific Corporation
Dec 22, 2021	HYDRATOME RX 44-20MM/450CM Material Number: M00583060	Sterility of device is compromised due to a sterile barrier breach	Class II	Boston Scientific Corporation
Nov 8, 2021	Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbe...	Manufacturing instructions did not include the directions to not retest the pneumatic kit compone...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of stricture...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of stricture...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictur...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictur...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Oct 21, 2021	HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strict...	Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonge...	Class II	Boston Scientific Corporation
Jul 23, 2021	TheraSphere Administration Set, REF OTT-SPE-FP-001 (990264.SPE)	Potential for leaks and loosening at the patient catheter connection	Class II	Boston Scientific Corporation
Jul 23, 2021	TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)	Potential for leaks and loosening at the patient catheter connection	Class II	Boston Scientific Corporation
Jun 3, 2021	Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f)...	Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito...	Class II	Boston Scientific Corporation
Jun 3, 2021	VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228	Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito...	Class II	Boston Scientific Corporation
Jun 3, 2021	VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/1...	The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P...	Class I	Boston Scientific Corporation
Jun 3, 2021	INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f...	The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P...	Class I	Boston Scientific Corporation
Jun 3, 2021	ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/...	The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P...	Class I	Boston Scientific Corporation
Jun 3, 2021	Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) ...	Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito...	Class II	Boston Scientific Corporation
Jun 3, 2021	INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/...	The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P...	Class I	Boston Scientific Corporation
Jun 3, 2021	Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f)...	Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito...	Class II	Boston Scientific Corporation
Jun 3, 2021	INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273	The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P...	Class I	Boston Scientific Corporation
Jun 3, 2021	Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722	Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito...	Class II	Boston Scientific Corporation
Jun 3, 2021	INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)	The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-P...	Class I	Boston Scientific Corporation
Jun 3, 2021	VALITUDE CRT-P pacemaker, Models: a) U125 b) U128	Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacito...	Class II	Boston Scientific Corporation
Apr 21, 2021	ELUVIA Drug-Eluting Vascular Stent System - Product Usage: indicated for impr...	One batch of the ELUVIATM Drug Eluting Vascular Stent System incorrect placement of some 6x40mm E...	Class II	Boston Scientific Corporation
Apr 15, 2021	Colpassist Vaginal Positioning Device - Product Usage: intended for use in ge...	Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render t...	Class II	Boston Scientific Corporation
Apr 15, 2021	UpsylonTM Y Mesh Kit with Colpassist Vaginal Positioning Device - Product Usa...	Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render th...	Class II	Boston Scientific Corporation
Apr 12, 2021	VICI RDS VENOUS STENT System Product Usage: is indicated for improving lum...	The firm has received reports of stent migration after implantation	Class I	Boston Scientific Corporation
Apr 12, 2021	VICI VENOUS STENT System Product Usage: is intended for the treatment of o...	The firm has received reports of stent migration after implantation	Class I	Boston Scientific Corporation
Mar 26, 2021	The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled system cont...	An AMS 700 100 mL Spherical Reservoir with InhibiZone was incorrectly labeled as a 100 mL Conceal...	Class II	Boston Scientific Corporation
Mar 16, 2021	EXALT Controller - Product Usage: intended for use with a Boston Scientific e...	May have been programmed with a less than optimal brightness setting resulting in a darker than ...	Class III	Boston Scientific Corporation
Mar 5, 2021	MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed i...	The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du...	Class II	Boston Scientific Corporation
Mar 5, 2021	MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter,...	The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters du...	Class II	Boston Scientific Corporation
Jan 19, 2021	Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UP...	Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa...	Class II	Boston Scientific Corporation
Jan 19, 2021	Captivator/Captiflex/Sensation Short Throw Single-Use Polypectomy Snares O...	Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa...	Class II	Boston Scientific Corporation
Jan 19, 2021	Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Sn...	Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a pa...	Class II	Boston Scientific Corporation
Dec 15, 2020	ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate g...	Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that d...	Class II	Boston Scientific Corporation
Dec 2, 2020	EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System;...	Accelerated battery depletion may result in a need for device replacement earlier than expected.	Class II	Boston Scientific Corporation
Dec 2, 2020	EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Mod...	Accelerated battery depletion may result in a need for device replacement earlier than expected.	Class II	Boston Scientific Corporation
Dec 2, 2020	EMBLEM MRI S-ICD Model A219	Electrical overstress may lead to device malfunction.	Class I	Boston Scientific Corporation
Dec 2, 2020	EMBLEM S-ICD Model A209	Electrical overstress may lead to device malfunction.	Class I	Boston Scientific Corporation
Dec 1, 2020	AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00...	The rotating luer fitting at the distal end of the delivery system handle may become detached fr...	Class II	Boston Scientific Corporation
Dec 1, 2020	Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS...	The rotating luer fitting at the distal end of the delivery system handle may become detached fr...	Class II	Boston Scientific Corporation
Dec 1, 2020	AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00...	The rotating luer fitting at the distal end of the delivery system handle may become detached fr...	Class II	Boston Scientific Corporation
Dec 1, 2020	Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS...	The rotating luer fitting at the distal end of the delivery system handle may become detached fr...	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.