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 14941–14960 of 38,428 recalls
Recalled Item: TactiCath Quartz Contact Force Ablation Catheter
The Issue: High rate of reported complaints for the loss
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fujifilm Synapse PACS Software Version 5.5.x and 5.7.x- intended as
The Issue: Lateromedial (LM) and Lateromedial Oblique (LMO) Orientation Markers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-900 Analyzer
The Issue: The Substrate Monitoring System in the AIA-900 Analyzer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VistaSolution
The Issue: A healthcare provider (HCP) noticed a patient had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Unity
The Issue: In TSM (Treatment Session Manager) Motion Monitoring workflows,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE
The Issue: A potential issue with a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA
The Issue: A potential issue with a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE
The Issue: A potential issue with a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product
The Issue: Modifications to MicroWell Qualitative Assay Parameters Not Retained-
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT 2
The Issue: A potential issue with a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE DUTCH
The Issue: A potential issue with a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System - Software Versions 3.3.3 and
The Issue: Modifications to MicroWell Qualitative Assay Parameters Not Retained-
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN
The Issue: A potential issue with a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT 7600 Integrated System Software Versions 3.5.1 and below
The Issue: Modifications to MicroWell Qualitative Assay Parameters Not Retained-
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA
The Issue: A potential issue with a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE
The Issue: A potential issue with a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH
The Issue: A potential issue with a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 SPANISH
The Issue: A potential issue with a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System Software Versions 3.3.3 and below Product
The Issue: Modifications to MicroWell Qualitative Assay Parameters Not Retained-
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Immunodiagnostic System - Product Code: 6802914 Unique
The Issue: Modifications to MicroWell Qualitative Assay Parameters Not Retained-
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.