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Medtronic Perfusion Systems recalls Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Recalled November 26, 2025 · FDA recall Z-0539-2026 · Medtronic Perfusion Systems
Hazard
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges. · FDA Class II
Units
3850 units
Sold at
US Nationwide distribution in the states of Hawaii and New York.
Description
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
Product
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →