Class II

Medical Device Recall: Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

Medtronic Perfusion Systems · October 20, 2025

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.

Distribution

US Nationwide distribution in the states of Hawaii and New York.

States Affected

NATIONWIDE

Quantity Affected

3850 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0539-2026

Status: ongoing

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