Browse Device Recalls
610 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 610 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 610 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 10, 2024 | Boston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Oct 10, 2024 | Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CR... | Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablatio... | Class I | Boston Scientific Corporation |
| Sep 6, 2024 | Boston Scientific myLUX Patient Application for an Apple Mobile device, Mode... | Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhon... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO I... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Sep 5, 2024 | Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM... | Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional vi... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covere... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal lumi... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covere... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (P... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covere... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered an... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC)... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covere... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC)... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covere... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | Class II | Boston Scientific Corporation |
| Aug 1, 2024 | WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covere... | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to... | 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.