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 4861–4880 of 38,428 recalls
Recalled Item: Presource kits and trays
The Issue: Cardinal Health is following the FDA's recommendations regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presource kits and trays
The Issue: Cardinal Health is following the FDA's recommendations regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presource kits and trays
The Issue: Cardinal Health is following the FDA's recommendations regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical
The Issue: for the CUSA Excel 23KHz Straight Handpiece
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Life2000 Ventilator
The Issue: for certain Life2000 ventilator systems to either
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch
The Issue: Grafts were found to have been approved, released,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CryoValve SG Pulmonary Human Heart Valve
The Issue: Grafts were found to have been approved, released,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software
The Issue: During positioning within the system's 3D to 3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software
The Issue: During positioning within the system's 3D to 3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software
The Issue: During positioning within the system's 3D to 3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter
The Issue: LIH Influence check settings for Lipemia are incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cue Health COVID-19 Test Cartridge Cue COVID-19 Test
The Issue: Due to modified test kits being marketed and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WOM Tube Set for lrrlgatlon
The Issue: Incorrect transponder data was written on the RFID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgical Image Guidance Functionality
The Issue: After surgery initiation, while using surgical image guidance,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gray Revision Instrument System Accessory Tray/Case
The Issue: The design of the HRIS Storage & Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HRIS Storage & Sterilization Case and Tray
The Issue: The design of the HRIS Storage & Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: When a DxI 9000 Access Immunoassay Analyzer is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter DxI 9000 Access Immunoassay Analyzer
The Issue: The reason for this recall is Beckman Coulter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Infinity 5
The Issue: Their is a potential that the implantable pulse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Infinity 7
The Issue: Their is a potential that the implantable pulse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.