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.
Showing 4181–4200 of 38,428 recalls
Recalled Item: Monarch Platform (Endoscopy)
The Issue: Endoscopy/bronchoscopy/urology devices may have a strain relief defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monarch Platform (Urology)
The Issue: Endoscopy/bronchoscopy/urology devices may have a strain relief defect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MAGNUM Disposable Core Tissue Biopsy Needle MN
The Issue: Due to possible packaging damage (indentations/cuts) cause by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transcend Product Name: Transcend Singles Universal Body (UB)
The Issue: Due to a manufacturing issue, red particulates present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transcend Product Name: Transcend Econo Kit (UB) -
The Issue: Due to a manufacturing issue, red particulates present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number:
The Issue: Due to a manufacturing issue, red particulates present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tablo Console
The Issue: Blood leak sensor, a component of hemodialysis device,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially
The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR-
The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially
The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- 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.
Recalled Item: WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered...
The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially
The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix M50 instrument -Intended for the rapid identification (ID)
The Issue: E. coli Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-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.
Recalled Item: WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially
The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WALLFLEX FC ESO STENT RMV 18X103MM- 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.
Recalled Item: WALLFLEX FC ESO STENT RMV 23X155MM- 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.
Recalled Item: AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile
The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WALLFLEX FC ESO STENT RMV 23X105MM- 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.