Z-0539-2026 Class II Ongoing
FDA device recall Z-0539-2026 was initiated by Medtronic Perfusion Systems on October 20, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3850 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2025
- Initiation Date
- October 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3850 units
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.
Distribution Pattern
US Nationwide distribution in the states of Hawaii and New York.
Code Information
UDI/DI 20763000433844, Lot Number 232135734