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 14961–14980 of 38,428 recalls
Recalled Item: Leica ARveo and M530 OH6 microscope systems.
The Issue: unintended interruption of surgical procedures due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Isolation Droplet Bundle Kit
The Issue: Roi CPS, LLC has become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respirator Crash Cart Kit
The Issue: Roi CPS, LLC has become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips SureSigns VM1SpO2
The Issue: Philips has identified a Philips SureSigns VM1 monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Patient Data Module (PDM) used with the following monitors:
The Issue: The CARESCAPE Patient Data Module (PDM) is used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mueller Knife Handle
The Issue: Becton Dickinson and Company, is conducting a voluntary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 6 Service Pack 2
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 8A Service Pack 1
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 5 Service Pack 3
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 6 Service Pack 3
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 9A
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 8B
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 9B Service Pack 1
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 8A
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 7
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 8B Service Pack 2
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 4.0 to RayStation 5 Service Pack 2 - Product
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 6
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 9B
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 6 Service Pack 1
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.