# FDA recall Z-0539-2026

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2025-10-20.

## 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.

## Distribution

US Nationwide distribution in the states of Hawaii and New York.

## Key facts

- **Recall number:** Z-0539-2026
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-20
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooklyn Park, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0539-2026

## Citation

> AI Analytics. FDA recall Z-0539-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0539-2026. Source: US FDA. Licensed CC0.

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