FDA Device recall Z-0539-2026
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 by Medtronic Perfusion Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0539-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-20 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | US |
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.
Identifiers
| code_info | UDI/DI 20763000433844, Lot Number 232135734 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0539-2026%22
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