Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 4201–4220 of 38,428 recalls

August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC)

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Becton Dickinson & Co.

Recalled Item: BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial

The Issue: E. coli Contamination

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC)

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered...

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially...

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially...

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F-

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
August 1, 2024· Boston Scientific Corporation

Recalled Item: AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing