---
title: "On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 — FDA record Z-2133-2026 | Is It on Recall"
description: "Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications."
url: https://isitonrecall.com/recall/fda-device-z-2133-2026-on-x-mitral-heart-valve-with-conform-x-sewing-ring-model-onxmc-25-33/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 — FDA record Z-2133-2026

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 Feb 1, 2026. 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**: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- **Reason**: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
- **Classification**: Class II
- **Recalling firm**: On-X Life Technologies, Inc.
- **Quantity**: 10
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2133-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2133-2026%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 | UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17 |

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

## Distribution

International distribution to the country of South Korea.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: May 20, 2026
- **Recall initiation date**: Feb 1, 2026
- **Center classification date**: May 8, 2026

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-2133-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [On-X Life Technologies, Inc. records](https://isitonrecall.com/brand/on-x-life-technologies-inc/)