Medtronic HR-ACT — Class II medical device recall Z-0539-2026
Ongoing recall by Medtronic Perfusion Systems, reported 2025-11-26, distributed nationwide. Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use
| Recall number | Z-0539-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Perfusion Systems, Brooklyn Park, MN, United States |
| Recall initiated | 2025-10-20 |
| Classified | 2025-11-18 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Quantity | 3,850 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20763000433844 |
| Lot numbers | 232135734 |
| Model numbers | 402-03 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0539-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.