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 6721–6740 of 38,428 recalls
Recalled Item: EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic...
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi)
The Issue: There is a manufacturing defect affecting specific rotator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT
The Issue: There is a manufacturing defect affecting specific rotator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1050 STOPCOCK LEFT ROTATOR OFF HANDLE
The Issue: There is a manufacturing defect affecting specific rotator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HIGH PRESSURE ROTATOR WITH MALE LUER LOCK
The Issue: There is a manufacturing defect affecting specific rotator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6IN PRESSURE TUBING
The Issue: There is a manufacturing defect affecting specific rotator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK
The Issue: There is a manufacturing defect affecting specific rotator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medex LOGICAL CATH LAB KIT
The Issue: There is a manufacturing defect affecting specific rotator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20IN (50.8CM) BRAIDED INJ LINE
The Issue: There is a manufacturing defect affecting specific rotator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medex 700PSI STOPCOCK W/ROTATOR
The Issue: There is a manufacturing defect affecting specific rotator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.