Medtronic recalls
44 federal recalls on file, showing the 31 from the last 12 months. We read every CPSC, FDA, USDA and NHTSA notice for Medtronic and put it in plain English.
Recent recalls
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Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541BMedtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
FDANov 19, 2025