Z-2133-2026Class II

On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

Name: Z-2133-2026 On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Creator: On-X Life Technologies, Inc.
Published: 2026-02-01
License: https://open.fda.gov/license/

On-X Life Technologies Inc. / initiated 2026-02-01 / Open, Classified

FDA source

On-X Life Technologies, Inc. began a recall of On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 on 2026-02-01. FDA classified it as Class II and gives the reason as "Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2133-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-02-01
Posted: 2026-05-08
Recalling firm: On-X Life Technologies Inc.
Product: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Product code: LWQ Heart-Valve, Mechanical
Reason for recall: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
FDA root cause: Under Investigation by firm
Action: On 2/1/2026, the firm contacted their customer to quarantine affected devices.
Quantity in commerce: 10
Distribution: International distribution to the country of South Korea.
Product codes and lots: UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2133-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2133-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-08

Product code LWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)