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 17621–17640 of 38,428 recalls
Recalled Item: Powerheart¿ G5 Automatic AED
The Issue: Sub-supplier s documentation for specific Printed Circuit Boards
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Up
The Issue: The potential sporadic performance problems may cause scanning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.All
The Issue: The potential sporadic performance problems may cause scanning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SunTech Medical Disposable
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies
The Issue: Calibration failures with Std.E, Sens.E, or Dup.E error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Microtainer Tube w/ BD Microgard Closure
The Issue: The products have been confirmed to have reduced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vereos PET/CT
The Issue: The Vereos PET/CT may have misaligned front and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion DIFFICULT IV KIT containing BD's Vacutainer Plastic Lithium Heparin
The Issue: False elevation of carboxyhemoglobin (COHb) results in blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter REF/Product...
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlidePath Long-Term Hemodialysis Catheter
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlidePath Long-Term Hemodialysis Catheter with Preloaded Stylet
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlidePath Long-Term Hemodialysis Catheter with Preloaded stylet
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlidePath Long-Term Hemodialysis Catheter
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EQUISTREAM Long-Term Hemodialysis Catheter with Preloaded Styet
The Issue: The action is being initiated due to complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.