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 18401–18420 of 38,428 recalls
Recalled Item: Horizon Cardiology Hemo
The Issue: users are not notified of procedure medication discrepancies
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia Ambition S (781359)
The Issue: Magnet Energization Device (MED) can have a residual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Berchtold Chromophare F628 Surgical Lights. Product Usage: The medical lights
The Issue: The back cover of the light head was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights
The Issue: The back cover of the light head was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TLS2 Thermal Ligating Shears
The Issue: The shears exhibited a high rate of complete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus...
The Issue: Kit label states not made with natural rubber
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios Alpha with software version VA30-mobile C-arm x-ray Material #
The Issue: Continuous operation of the Cios Alpha at high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ChemoPlus Chemo Spill Kit
The Issue: Kit label states not made with natural rubber
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage:...
The Issue: Kit label states not made with natural rubber
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus...
The Issue: Kit label states not made with natural rubber
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rifton TRAM Standard Base
The Issue: A design change to the load-bearing quick release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rifton TRAM Low Base
The Issue: A design change to the load-bearing quick release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rifton E-Pacer
The Issue: A design change to the load-bearing quick release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard ¿ custom surgical pack labeled as "LAPAROSCOPIC - OSU"
The Issue: Resource Optimization & Innovation (ROi) has received a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard ¿ custom surgical pack labeled as "LAP - FLOL
The Issue: Resource Optimization & Innovation (ROi) has received a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prometra Programmable Pump
The Issue: The pump shuts down unexpectedly if Error 115,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prometra Clinician Programmer (Touchscreen) Software version 2.00.29
The Issue: The pump shuts down unexpectedly if Error 115,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prometra Programmer (Grand Prime) Software version 2.00.29
The Issue: The pump shuts down unexpectedly if Error 115,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prometra II Programmable Pump
The Issue: The pump shuts down unexpectedly if Error 115,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prometra II Programmable Pump (Clinical)
The Issue: The pump shuts down unexpectedly if Error 115,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.