FDA Medical devices recall ·
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges) recall
- Recall number
- Z-0539-2026
- Date
- (initiated October 20, 2025)
- Company / brand
- Medtronic Perfusion Systems
7611 Northland Dr N, Brooklyn Park, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3850 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 20763000433844, Lot Number 232135734
Distribution
US Nationwide distribution in the states of Hawaii and New York.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0539-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.