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 37521–37540 of 38,428 recalls
Recalled Item: System 8000 Base Product Usage: The Sarns Modular Perfusion System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03...
The Issue: Defibrillator/monitor cannot analyze an ECG report during acquisition
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx monitor/defibrillators Models: M3535A
The Issue: HeartStart MRx Unexpected Pads/Paddles ECG Failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Access & Return Line Set
The Issue: The recalled product leaks at the connection site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EOS X-ray Medical Diagnostic
The Issue: It was discovered of several generator failures of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD NX Cassette
The Issue: Advanced Sterilization Products (ASP) is recalling (removing) the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 100S Cassette
The Issue: Advanced Sterilization Products (ASP) is recalling (removing) the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion EnVe Ventilator Designed for use on patients who require
The Issue: CareFusion identified that the EnVe Ventilator may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker brand Arthroscope and Hardware Set Tray (sterilization tray)
The Issue: The gravity steam, Ethylene Oxide (EO) and STERRAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe N Simple No-Sting Skin Barrier Film
The Issue: The firm received a customer complaint of observed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS)
The Issue: Synthes is initiating a Medical Device Labeling Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Modular Perfusion System 9000
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Modular Perfusion System 9000
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Modular Perfusion System 8000 base
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varian brand Varian Eclipse Treatment Planning System for radiotherapy
The Issue: Varian has identified an anomaly with the Eclipse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Modular Perfusion System 8000 base
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1. System 1 base 220/240V. The
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Modular Perfusion System 8000 base
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Modular Perfusion System 8000 base
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Modular Perfusion System 9000
The Issue: Terumo Cardiovascular Systems has received several reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.