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.

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Date	Product	Reason	Class	Firm
Jul 19, 2019	AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: ...	Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..	Class II	Boston Scientific Corporation
Apr 8, 2019	AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: ...	Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue...	Class II	Boston Scientific Corporation
Apr 8, 2019	AURIGA 30 GENERAL - DEMO SYSTEM UPN: M0068S30GD0 Product Usage: The Au...	Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue...	Class II	Boston Scientific Corporation
Apr 8, 2019	AURIGA XL 4007 GENERAL - DEMO SYSTEM UPN: M0068FS4007GD0 Product Usage: ...	Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue...	Class II	Boston Scientific Corporation
Apr 8, 2019	AURIGA XL 4007 GENERAL SYSTEM UPN: M0068FS4007G0 Product Usage: The Aur...	Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue...	Class II	Boston Scientific Corporation
Apr 8, 2019	AURIGA 30 GENERAL SYSTEM UPN: M0068S30G0 Product Usage: The Auriga XL ...	Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue...	Class II	Boston Scientific Corporation
Apr 8, 2019	AURIGA 30 BRAZIL SYSTEM UPN: M0068S30B0 Product Usage: The Auriga XL 4...	Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue...	Class II	Boston Scientific Corporation
Apr 8, 2019	AURIGA XL 4007 BRAZIL SYSTEM Model: M0068FS4007B0 Product Usage: The A...	Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue...	Class II	Boston Scientific Corporation
Apr 8, 2019	AURIGA 30 GENERAL ZERO COST SYSTEM UPN: M0068S30GZ0 Product Usage: The...	Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue...	Class II	Boston Scientific Corporation
Apr 8, 2019	AURIGA 30 BRAZIL ZERO COST SYSTEM UPN: M0068S30BZ0 Product Usage: The A...	Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue...	Class II	Boston Scientific Corporation
Dec 26, 2018	Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, M...	The sterile barrier may contain packaging seal defects.	Class II	Boston Scientific Corporation
Dec 26, 2018	Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Ma...	The sterile barrier may contain packaging seal defects.	Class II	Boston Scientific Corporation
Dec 19, 2018	Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of b...	A batch of 185cm Stingray Guidewires are incorrectly labeled as 300cm guidewires.	Class II	Boston Scientific Corporation
Nov 28, 2018	IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irri...	Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change...	Class III	Boston Scientific Corporation
Nov 28, 2018	Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrig...	Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change...	Class III	Boston Scientific Corporation
Nov 28, 2018	IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irri...	Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These change...	Class III	Boston Scientific Corporation
Nov 1, 2018	The SQ-RX Pulse Generator a component of the Subcutaneous Implantable Cardiov...	Experienced accelerated battery depletion and a shortened replacement interval due to latent inte...	Class II	Boston Scientific Corporation
Sep 10, 2018	VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Sci...	There is a potential for the Pacing System Analyzer (PSA) to exhibit unintended cross-chamber sti...	Class II	Boston Scientific Corporation
Sep 10, 2018	ESSENTIO Pacemaker	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	ACCOLADE Pacemaker	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	PROPONENT Pacemaker	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Sep 10, 2018	VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)	Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an eleva...	Class II	Boston Scientific Corporation
Jun 20, 2018	Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14...	Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablati...	Class II	Boston Scientific Corporation
Feb 12, 2018	Capio RP; Model #M0068321010. Intended for use in general suturing applica...	Potential for Capio sutures to break and /or detach.	Class II	Boston Scientific Corporation
Feb 12, 2018	Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use i...	Potential for Capio sutures to break and /or detach.	Class II	Boston Scientific Corporation
Feb 12, 2018	Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in g...	Potential for Capio sutures to break and /or detach.	Class II	Boston Scientific Corporation
Feb 12, 2018	Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue rei...	Potential for Capio sutures to break and /or detach.	Class II	Boston Scientific Corporation
Feb 12, 2018	Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinfo...	Potential for Capio sutures to break and /or detach.	Class II	Boston Scientific Corporation
Feb 12, 2018	Uphold Vaginal Support System; Model #M0068317080. Indicated for tissue re...	Potential for Capio sutures to break and /or detach.	Class II	Boston Scientific Corporation
Feb 12, 2018	PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue rei...	Potential for Capio sutures to break and /or detach.	Class II	Boston Scientific Corporation
Feb 12, 2018	Capio CL; Model #M0068311350. Indicated for the placement of suture in a v...	Potential for Capio sutures to break and /or detach.	Class II	Boston Scientific Corporation
Feb 12, 2018	PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tiss...		Class II	Boston Scientific Corporation
Feb 12, 2018	Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use ...	Potential for Capio sutures to break and /or detach.	Class II	Boston Scientific Corporation
Feb 12, 2018	Capio SLIM Box 5, Model #M0068318261; Intended for use in general suturin...	Potential for Capio sutures to break and /or detach.	Class II	Boston Scientific Corporation
Dec 20, 2017	SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600	Certain lots of devices may have the working channel sleeve protruding from the camera cap which ...	Class II	Boston Scientific Corporation
Dec 12, 2017	Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 12, 2017	Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 12, 2017	Malecot Nephrostomy Catheter System, Product Number: M001224110, GTIN: 087147...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 12, 2017	Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 12, 2017	Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 12, 2017	Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 ...	Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use.	Class II	Boston Scientific Corporation
Dec 11, 2017	Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a ne...	Potential polymer material degradation.	Class II	Boston Scientific Corporation
Dec 7, 2017	PROPONENT MRI Pacemaker	Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV...	Class II	Boston Scientific Corporation
Dec 7, 2017	ESSENTIO MRI DR Pacemaker	Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV...	Class II	Boston Scientific Corporation
Dec 7, 2017	ALTRUA 2 DR Pacemaker	Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV...	Class II	Boston Scientific Corporation
Dec 7, 2017	PROPONENT VDD SL Pacemaker	Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV...	Class II	Boston Scientific Corporation
Dec 7, 2017	VISIONIST X4 CRT-P Pacemaker	Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV...	Class II	Boston Scientific Corporation
Dec 7, 2017	ESSENTIO EL DR Pacemaker	Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV...	Class II	Boston Scientific Corporation
Dec 7, 2017	VALITUDE X4 CRT-P Pacemaker	Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV...	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.