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 35801–35820 of 38,428 recalls
Recalled Item: AU2700 Clinical Chemistry Analyzer AU5400 Clinical Chemistry Analyzer...
The Issue: Beckman Coulter is recalling AU2700/AU2700 Plus & AU5400
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vermed
The Issue: On 4/18/13 HEARTSYNC became aware of a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mini Cannulated Titanium Headed and Headless Screw Set and 2.5
The Issue: Faded and wrong markings on bone screw Countersink/Depth
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******iMRI Handpiece. Use with iMRI System Only***Rx Only***Manufacturer: The
The Issue: The firm Anspach Effort of Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort
The Issue: The firm Anspach Effort of Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort
The Issue: The firm Anspach Effort of Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ******microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort
The Issue: The firm Anspach Effort of Palm Beach Gardens,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is
The Issue: Siemens has confirmed that the TACR method may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S-LIFT Slap Hammer
The Issue: Malfunction of slap hammer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydra Vision DR 60/80 System
The Issue: A complaint was received in which a hospital
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B-CrossLaps/serum (B-CTx in serum) 160 100 tests Immunoassay
The Issue: Roche Diagnostics internal investigations in R&D have shown
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView SPECT gamma camera for Emission Computed Tomography
The Issue: Philips has received one report from the field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fluoroscan Mini C-arm InSight
The Issue: The audible alarm to alert the operator when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fluoroscan Mini C-arm InSight2
The Issue: The audible alarm to alert the operator when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: embla Embletta Gold (It functions as a Polysomnography Recorder and
The Issue: Calibration error for Embla Embletta Gold units calibrated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The...
The Issue: Holes and/or tears can be introduced in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT
The Issue: Holes and/or tears can be introduced in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The...
The Issue: Holes and/or tears can be introduced in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The...
The Issue: Holes and/or tears can be introduced in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT
The Issue: Holes and/or tears can be introduced in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.