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 37761–37780 of 38,428 recalls
Recalled Item: 24FR FLEX ART CANN NON STERILE. The Sarns High Flow
The Issue: During production of one lot of the Sarns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR
The Issue: During production of one lot of the Sarns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR
The Issue: During production of one lot of the Sarns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR
The Issue: During production of one lot of the Sarns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA
The Issue: for the sterility barrier to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR
The Issue: During production of one lot of the Sarns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA
The Issue: for the sterility barrier to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic
The Issue: During production of one lot of the Sarns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch
The Issue: During production of one lot of the Sarns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA
The Issue: for the sterility barrier to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA
The Issue: for the sterility barrier to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula
The Issue: During production of one lot of the Sarns
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA
The Issue: for the sterility barrier to be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ON-Q pump with ONDEMAND bolus button
The Issue: It was determined that in a small quantity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12
The Issue: Siemens Healthcare Diagnostics has confirmed that the presence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
The Issue: Sharp edge on the body/housing of the Lynx
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V Series Patient Monitors
The Issue: Mindray has identified two software anomalies contained in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BeautyAngel Health Fitness Natural Collagen Stimulation Anti Aging For human
The Issue: The Beauty Angel was marketed without a 510k
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO VirtuTRAX Instrument Navigator
The Issue: The general purpose electromagnetic sensor was incorrectly calibrated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIVCO General Purpose Sensor
The Issue: The general purpose electromagnetic sensor was incorrectly calibrated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.