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 3481–3500 of 38,428 recalls
Recalled Item: Discovery MR750w 3.0T
The Issue: Gradient coils for certain MR systems (see affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex Venn Reusable Tracheal Tube Introducer
The Issue: Smiths Medical has identified a potential for ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Architect
The Issue: Gradient coils for certain MR systems (see affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tomographic Imager Combining Emission Computed Tomography With Nuclear...
The Issue: Gradient coils for certain MR systems (see affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a
The Issue: Due to incorrect labels applied to devices during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Galaxy System (GAL-001)
The Issue: Bronchoscopic system uninterruptable power may have defective component,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Galaxy bronchoscope (Product GALB-001) used with Instructions for use
The Issue: Not all biopsy tools meant to fit bronchoscope
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDO KIT
The Issue: Identified lots of Olympus product may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Proteus XR/A radiographic system
The Issue: Steel cables in the Wall Stand for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICRO-X Rover Mobile X-ray System
The Issue: During internal testing it was found that if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp
The Issue: There has been an increase in the number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.