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 12681–12700 of 38,428 recalls
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended
The Issue: Recall reason is possible sporadic false negative conventional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac
The Issue: The device may contain a manufacturing defect of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Catheters contain two issues: 1. the inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP A40 System Silver
The Issue: Certain devices were built with motor assemblies that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP A30
The Issue: Certain devices were built with motor assemblies that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP A40 System Silver
The Issue: Certain devices were built with motor assemblies that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP A40
The Issue: Certain devices were built with motor assemblies that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP A40
The Issue: Certain devices were built with motor assemblies that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiPAP V30 Auto
The Issue: Certain devices were built with motor assemblies that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female
The Issue: The firm received a complaint regarding particulate found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareLink SmartSync Device Manager (24970A). used to interrogate cardiac...
The Issue: There is a SmartSync software issue that results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareLink SmartSync Device Manager - Product Usage: used to treat
The Issue: A longevity estimation error may occur in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implantable Pulse Generators - Product Usage: used to treat arrhythmias
The Issue: A longevity estimation error may occur in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01
The Issue: There is a SmartSync software issue that results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Programmers - Product Usage: used to treat arrhythmias related to
The Issue: A longevity estimation error may occur in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product...
The Issue: A longevity estimation error may occur in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.