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 18321–18340 of 38,428 recalls
Recalled Item: Drill
The Issue: An investigation identified that the products were possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill
The Issue: An investigation identified that the products were possibly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediPress pneumatic compression system
The Issue: Product design change did not receive proper premarket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient
The Issue: Product design change did not receive proper premarket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient
The Issue: Product design change did not receive proper premarket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient
The Issue: Product design change did not receive proper premarket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient
The Issue: Product design change did not receive proper premarket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient
The Issue: Product design change did not receive proper premarket
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Concorde Lift
The Issue: A complaint trend was observed for post-operative loss
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Concorde Lift
The Issue: A complaint trend was observed for post-operative loss
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i Processing Module
The Issue: loose cable connections on the reagent cooler,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TactiSys Quartz Equipment (with software version 1.7) Model: PN-004 400
The Issue: In reported cases, the device log on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SoundWave Professional Suite Software 3.2
The Issue: The manufacturer received complaints that customers were attempting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas p 501 post-analytical units
The Issue: There is a potential for the tray input
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas p 701 post-analytical units
The Issue: There is a potential for the tray input
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Delfi Medical Innovations
The Issue: Delfi Medical Innovations Inc has discovered that tourniquets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER
The Issue: Delfi Medical Innovations Inc has discovered that tourniquets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test
The Issue: An elevated lot-to-lot bias was observed for Autoimmune
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number:...
The Issue: Power Logic Board Fail Message on the 2008T
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adapter for handpiece
The Issue: Dental adaptor does not conform to specifications. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.