Medtronic Perfusion Systems recalls Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
- Recall date
- October 20, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0539-2026
- FDA classification
- Class II
- Brand / firm
- Medtronic Perfusion Systems
- Sold / distributed
- US Nationwide distribution in the states of Hawaii and New York.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
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