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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DateProductReasonClassFirm
Feb 10, 2026 EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner ... Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on ... Class II Boston Scientific Corporation
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Materia... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Ma... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Materia... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; ... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Mater... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 19, 2025 HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Mat... Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... Class I Boston Scientific Corporation
Dec 3, 2025 Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1... Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Per... Class II Boston Scientific Corporation
Sep 11, 2025 CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (1... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (1... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12C... The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 TENACIO Pump with InhibiZone; UPN: 72404429; The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Sep 11, 2025 TENACIO Pump without InhibiZone; UPN: 72404420; The potential for devices to experience inflation and/or deflation performance issues or difficul... Class II Boston Scientific Corporation
Aug 28, 2025 Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12m... The product in incorrectly labeled. The label indicates that the skive hole should be above the b... Class II Boston Scientific Corporation
Aug 20, 2025 ACCOLADE DR SL MRI (Model L311) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number S722, ALTRUA 2 DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 PROPONENT DR SL (Model L201) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE SR SL MRI (Model L310) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L100, ESSENTIO SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U125, VALITUDE CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE SR SL (Model L300) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L111, ESSENTIO DR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number S701 ALTRUA 2 SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE DR EL (Model L321) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE DR SL (Model L301) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L210 PROPONENT SR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U225 VISIONIST CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L110, ESSENTIO SR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 ACCOLADE DR EL MRI (Model L331) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L131, ESSENTIO DR EL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U228, VISIONIST CRT-P EL MRI Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L101, ESSENTIO DR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L231, PROPONENT DR EL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U128, VALITUDE CRT-P EL MRI Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L211 PROPONENT DR SL MRI Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L121 ESSENTIO DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L221 PROPONENT DR EL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 PROPONENT SR SL (Model L200) Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number U226, VISIONIST CRT-P EL Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number L209 PROPONENT DR (VDD) SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 20, 2025 Model Number S702, ALTRUA 2 DR SL Pacemaker Software to enhance Safety Architecture is available and designed to prevent initiation of Safety... Class I Boston Scientific Corporation
Aug 18, 2025 Preventive Maintenance (PM) Kit ICEFX, Material Number (UPN) SPRPM8000 Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. Class II Boston Scientific Corporation
Aug 18, 2025 ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Ma... Certain desiccant tube subassemblies were built with end caps that were not correctly tightened. Class II Boston Scientific Corporation
Aug 5, 2025 Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H749045... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Aug 5, 2025 Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Aug 5, 2025 Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Aug 5, 2025 Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; ... The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pres... Class II Boston Scientific Corporation
Jul 29, 2025 WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; i... Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... Class I 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.