Medtronic Perfusion Systems recalls Medtronic HR-ACT
- Recalling company
- Medtronic Perfusion Systems
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 20, 2025
- Reported
- Nov 26, 2025
- Distribution
- US Nationwide distribution in the states of Hawaii and New York.
- Status
- Ongoing
- Quantity
- 3850 units
- Lot / codes
- UDI/DI 20763000433844, Lot Number 232135734
- Company location
- Brooklyn Park, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0539-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0539-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.