Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medtronic HR-ACT (High Range Activated Clotting Time Cartridges) Recalled by Medtronic Perfusion Systems Due to Medtronic personnel observed trace amounts of dry blood...

Date: October 20, 2025
Company: Medtronic Perfusion Systems
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Perfusion Systems directly.

Affected Products

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

Quantity: 3850 units

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Perfusion Systems

Medtronic Perfusion Systems has 96 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report