# FDA recall Z-0487-2026

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2025-09-12.

## Product

Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B

## Reason for recall

Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.

## Distribution

US States: AZ, CA, TN

## Key facts

- **Recall number:** Z-0487-2026
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-12
- **Report date:** 2025-11-19

- **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-0487-2026

## Citation

> AI Analytics. FDA recall Z-0487-2026. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0487-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*