FDA recall Z-0539-2026

Medtronic Perfusion Systems · Class II · device

Product

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.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2025-10-20
Report date: 2025-11-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brooklyn Park, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0539-2026