---
title: "Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardi... — FDA record Z-0487-2026 | Is It on Recall"
description: "Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements."
url: https://isitonrecall.com/recall/fda-device-z-0487-2026-affinity-nt-oxygenator-oxygenator-with-balance-biosurface-and-uncoated-cardiotomy-venous-reservoir-p/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B — FDA record Z-0487-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 12, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
- **Reason**: Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
- **Classification**: Class II
- **Recalling firm**: Medtronic Perfusion Systems
- **Quantity**: 26 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0487-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0487-2026%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot Number: 231621003; Unit Serial Number: 5117755016; UDI-DI: 00763000187842, 20763000187846 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US States: AZ, CA, TN

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)

## Dates in the source

- **Report date**: Nov 19, 2025
- **Recall initiation date**: Sep 12, 2025
- **Center classification date**: Nov 10, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0487-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Perfusion Systems records](https://isitonrecall.com/brand/medtronic-perfusion-systems/)