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 31441–31460 of 38,428 recalls
Recalled Item: Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
The Issue: LeadCare Plus and LeadCare Ultra Blood Lead Testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
The Issue: LeadCare Plus and LeadCare Ultra Blood Lead Testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carousel MAS1025-01
The Issue: In some situations the carousel position pin (locker)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SoftPath Laboratory Information System. Versions 4.3.0.8
The Issue: Modifications to diagnostic text may be: 1) Saved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VisiPlugST for the Lacrimal Efficiency Test. It is also sold
The Issue: Moisture level may cause the VisiPlugST (or CollaSyn
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Harmony¿ vLED Surgical Lighting System
The Issue: STERIS has learned that groups of LED lights
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GETINGE 46-SERIES Medical Washer-Disinfector
The Issue: Getinge Disinfection AB received complaints regarding sediment residuals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TactiSys Quartz Pack
The Issue: A configuration update needs to be done on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer PERSONA Tibial Articular Surface Inserter
The Issue: for fracture of the tip of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenSmart
The Issue: Nonin Medical is conducting a recall of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRX-Revolution Mobile X-Ray System
The Issue: While servicing a unit at a customer site,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Autoject E1 Fixed needle device
The Issue: The syringe carrier is missing components: a damper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component
The Issue: Fully threaded Taper Post Fixation components not cleared
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component
The Issue: Fully threaded Taper Post Fixation components not cleared
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component
The Issue: Fully threaded Taper Post Fixation components not cleared
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Athrosurface 40mm 13.75x31mm Taper Post Fixation Component
The Issue: Fully threaded Taper Post Fixation components not cleared
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component
The Issue: Fully threaded Taper Post Fixation components not cleared
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Myoglobin Calibrator (MYO CAL)
The Issue: Dimension Vista Myoglobin Calibrator (MYO CAL) may produce
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bronchial Double Lumen Tube Set (Right)
The Issue: Customer complaints reporting that the cobb connector detached
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carlens Bronchial Double Lumen Tube Set (Left) Sterile
The Issue: Customer complaints reporting that the cobb connector detached
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.