Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
FDA Recall #Z-0539-2026 — Class II — October 20, 2025
Product Description
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Reason for Recall
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.
Recalling Firm
Medtronic Perfusion Systems — Brooklyn Park, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3850 units
Distribution
US Nationwide distribution in the states of Hawaii and New York.
Code Information
UDI/DI 20763000433844, Lot Number 232135734
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated