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 6821–6840 of 38,428 recalls
Recalled Item: ZEUS ELISA Parvovirus B19 IgG Test System
The Issue: The organization completed a product improvement process to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acrobat-i Vacuum Positioner System
The Issue: The Positioner Arm may not tighten or lock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The 4Kscore Test
The Issue: Mathematical modeling of the 4Kscore with and without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT
The Issue: Updates to the HVAD system instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS
The Issue: Updates to the HVAD system instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA
The Issue: Updates to the HVAD system instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT
The Issue: Updates to the HVAD system instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT
The Issue: Updates to the HVAD system instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US
The Issue: Updates to the HVAD system instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US)
The Issue: Updates to the HVAD system instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT
The Issue: Updates to the HVAD system instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP
The Issue: Updates to the HVAD system instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Small DKS Disposable Kerrison System
The Issue: Units were not intended for commercial distribution and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DKS Disposable Kerrison System
The Issue: Units were not intended for commercial distribution and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Snapshot NIR
The Issue: Tissue oxygenation measurement system touchscreens may be unresponsive,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m HCV AMP kit
The Issue: Abbott has received reports of an increase in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHYSICA HPS Tibial Liner #6 H10 .54.610
The Issue: Due to incorrect product labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: vyaire Flexible Patient Circuit
The Issue: Two patient circuits, 29028-003 and 29028-004, for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: vyaire Flexible Patient Circuit
The Issue: Two patient circuits, 29028-003 and 29028-004, for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in
The Issue: RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.