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 11721–11740 of 38,428 recalls
Recalled Item: Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial
The Issue: Base plate may detach from the main body
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: United Orthopedics USTAR II Knee System USTAR II Knee System Segment Part
The Issue: Due to product not meeting specification for concentricity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EcoLotion Transmission Lotion
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Norco Ultrasound Gel
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 ga ARS Decompression Needle
The Issue: The device includes the incorrect Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Pioneer nuclear magnetic resonance imaging system
The Issue: Under certain conditions, some slices may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima MR450w 1.5T nuclear magnetic resonance imaging system
The Issue: Under certain conditions, some slices may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
The Issue: Under certain conditions, some slices may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Architect nuclear magnetic resonance imaging system
The Issue: Under certain conditions, some slices may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Creator
The Issue: Under certain conditions, some slices may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MR750w 3.0T nuclear magnetic resonance imaging system
The Issue: Under certain conditions, some slices may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Voyager nuclear magnetic resonance imaging system
The Issue: Under certain conditions, some slices may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Artist nuclear magnetic resonance imaging system
The Issue: Under certain conditions, some slices may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MR750 3.0T nuclear magnetic resonance imaging system
The Issue: Under certain conditions, some slices may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Premier nuclear magnetic resonance imaging system
The Issue: Under certain conditions, some slices may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Pneumostat Chest Drain Valve
The Issue: The firm is revising the Indication for Use,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative...
The Issue: Labeled On-board instrument stability issue for current and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic
The Issue: Labeled On-board instrument stability issue for current and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative...
The Issue: Labeled On-board instrument stability issue for current and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Operating room table - Product Usage: intended for use during
The Issue: ORT200/300 rotational lock may fail to function such
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.