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 17461–17480 of 38,428 recalls
Recalled Item: RX Daytona
The Issue: There was a report of a malfunction with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX Imola
The Issue: There was a report of a malfunction with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Unity
The Issue: The QA software solution to perform the MR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TAPSYSTEM Model 2A
The Issue: There is a potential for an assembly error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped
The Issue: Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Norm-O-Temp model 111Z
The Issue: The manual does not provide instruction stating that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Norm-O-Temp model 111W
The Issue: The manual does not provide instruction stating that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELLIPSE VR
The Issue: Electrical failures were identified in cardioverter defibrillators (ICDs)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELLIPSE DR
The Issue: Electrical failures were identified in cardioverter defibrillators (ICDs)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELLIPSE DR
The Issue: Electrical failures were identified in cardioverter defibrillators (ICDs)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELLIPSE VR
The Issue: Electrical failures were identified in cardioverter defibrillators (ICDs)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELLIPSE DR
The Issue: Electrical failures were identified in cardioverter defibrillators (ICDs)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELLIPSE VR
The Issue: Electrical failures were identified in cardioverter defibrillators (ICDs)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios care fusion system
The Issue: DAP chamber may be missing an insulating foil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios Alpha VA20/ VA30 mobile X-Ray systems
The Issue: DAP chamber may be missing an insulating foil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Seca 402/403 Baby Scale Cart
The Issue: It has been determined that the wheels on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Co-Flex Med 4" - Product Usage: Single Use secondary
The Issue: Incomplete packaging seal of sterile product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Co-Flex NL 3" - Product Usage: Single Use secondary
The Issue: Incomplete packaging seal of sterile product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary
The Issue: Incomplete packaging seal of sterile product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Co-Flex Med 3" - Product Usage: Single Use secondary
The Issue: Incomplete packaging seal of sterile product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.