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 26681–26700 of 38,428 recalls
Recalled Item: AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
The Issue: The possibility exists for contaminants, in the form
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6F/7F MynxGrip Vascular Closure Device
The Issue: A total of 70 6F/7F Mynx Grip devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Viva-ProE Systems
The Issue: Software malfunction; The action being taken due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Radiology
The Issue: The STAT priority icon was not displayed in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quattro Air FFM MED AMER
The Issue: Masks in this lot, labelled and sold as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED
The Issue: dull knife edge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laseredge 1.1mm Arrow Knife Angled
The Issue: dull knife edge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SURESTEP Tray
The Issue: The product contained a latex catheter instead of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5%
The Issue: B. Braun Medical Inc. is voluntarily recalling specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Option-vm Urinary Catheter. Male use only. Latex Free. Sterile
The Issue: During an FDA inspection it was found out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinity Biotech Captia Measles IgM
The Issue: The product lot failed to meet QC acceptance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Option-vf Urinary Catheter. Female use only. Latex Free. Sterile
The Issue: During an FDA inspection it was found out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere INRatio PT/INR Test Strips Model Number: 0100071
The Issue: Alere San Diego is initiating a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 Product Usage:
The Issue: Alere San Diego is initiating a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A...
The Issue: Alere San Diego is initiating a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU
The Issue: Alere San Diego is initiating a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panacea Air Pro Mattress Control Unit
The Issue: The Panacea Air Pro Mattress Control Unit is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product
The Issue: Alere San Diego is initiating a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio
The Issue: Alere San Diego is initiating a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product
The Issue: Alere San Diego is initiating a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.