Medtronic Perfusion Systems: Medical Device Recall in 2025 - (Recall #: Z-0539-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 20, 2025

Date Posted: November 26, 2025

Recall Number: Z-0539-2026

Event ID: 97912

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.

Status: Ongoing

Product Quantity: 3850 units

Code Information:

UDI/DI 20763000433844, Lot Number 232135734

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated