Browse Device Recalls
638 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 638 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 638 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Jul 29, 2025 | WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; ... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; i... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intend... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; i... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; ... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 29, 2025 | WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; in... | Boston Scientific has identified a higher likelihood of air embolism events when procedures are p... | Class I | Boston Scientific Corporation |
| Jul 24, 2025 | ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardiover... | Affected lead models may experience gradually rising LVSI measurements in association with calcif... | Class I | Boston Scientific Corporation |
| Jul 24, 2025 | RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lea... | Affected lead models may experience gradually rising LVSI measurements in association with calcif... | Class I | Boston Scientific Corporation |
| Jul 24, 2025 | ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead,... | Affected lead models may experience gradually rising LVSI measurements in association with calcif... | Class I | Boston Scientific Corporation |
| Jul 7, 2025 | Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, s... | Certain batches are being removed due to an increase in complaints received in which physicians e... | Class I | Boston Scientific Corporation |
| Jun 25, 2025 | FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 | The potentially impacted units were manufactured using specific equipment that may have caused cr... | 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.