Recall Z-0539-2026— Medtronic Perfusion Systems

Name: FDA recall Z-0539-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-20

Class II · Ongoing

Class II FDA medical device recall by Medtronic Perfusion Systems, initiated 2025-10-20. It names one FDA 510(k) clearance: K860122. Product: Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03. Reason: 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..

Recalling firm: Medtronic Perfusion Systems
Classification: Class II
Status: Ongoing
Initiated: 2025-10-20
Firm location: Brooklyn Park, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K860122 — HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIMEMedical Device Consultants, Inc.·cleared 1986-04-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.