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 19121–19140 of 38,428 recalls
Recalled Item: Edwards Lifesciences Swan Ganz Thermodilution Catheter
The Issue: These Swan Ganz catheters have incorrect lumen assembly,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan Ganz Thermodilution Catheter
The Issue: These Swan Ganz catheters have incorrect lumen assembly,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan Ganz Thermodilution Catheter
The Issue: These Swan Ganz catheters have incorrect lumen assembly,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Swan Ganz Thermodilution Catheter
The Issue: These Swan Ganz catheters have incorrect lumen assembly,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID Circuit Basic 180
The Issue: Incorrectly pre-assembled breathing circuit has potential for incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Watertrap (P) 180
The Issue: Incorrectly pre-assembled breathing circuit has potential for incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Basic 250
The Issue: Incorrectly pre-assembled breathing circuit has potential for incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID Circuit Watertrap (P) 180
The Issue: Incorrectly pre-assembled breathing circuit has potential for incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Basic (P) 250
The Issue: Incorrectly pre-assembled breathing circuit has potential for incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Basic 180
The Issue: Incorrectly pre-assembled breathing circuit has potential for incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Basic (P) 180
The Issue: Incorrectly pre-assembled breathing circuit has potential for incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID Circuit Basic 250
The Issue: Incorrectly pre-assembled breathing circuit has potential for incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Anesthesia WT(P) 180
The Issue: Incorrectly pre-assembled breathing circuit has potential for incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSCO 5000 Series Washer/Disinfector Model # 5052
The Issue: The software in the systems may not process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSCO 3000 Series Washer/Disinfector Model # 3052
The Issue: The software in the systems may not process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoenix AST Indicator
The Issue: Panels inoculated using certain lots of the indicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoenix AP AST Indicator Bag
The Issue: Panels inoculated using certain lots of the indicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoenix AST-s Indicator
The Issue: Panels inoculated using certain lots of the indicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
The Issue: Presence of natural rubber latex is not declared
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The WinStation Retinal Imager
The Issue: Certain configurations of Merge Eye Station hardware may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.