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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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DateProductReasonClassFirm
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
Mar 7, 2018 Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Self-Expanding... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding St... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent RP Endoprosthesis Tracheobronchial Transhepatic B... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Endoprosthesis Tracheobronchial Self-Expanding St... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Enteral Endoprosthesis Colonic/Duodenal Stent, 22... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
Mar 7, 2018 Boston Scientific Wallstent Endoprosthesis Tracheobronchial Transhepatic Bili... The expiration date on the device labeling exceeds its actual validated shelf life because the st... Class II SPS Sterilization, Inc
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
Dec 7, 2017 ACCOLADE 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 ESSENTIO MRI 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 ESSENTIO MRI SR 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 SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ESSENTIO SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE MRI SR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE 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 PROPONENT 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 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 PROPONENT DR Pacemaker Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV... Class II Boston Scientific Corporation
Dec 7, 2017 ACCOLADE MRI EL DR 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.