FDA recall, , Moderate risk
On-X Mitral Heart Valve with Conform-X Sewing Ring
The On-X Mitral Heart Valve with Conform-X Sewing Ring was released before all required testing was complete.
Summary by Recall Canary from the FDA notice
What happened
On-X Life Technologies, Inc., of Austin, Texas, is voluntarily recalling the On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33. The heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. The firm began the recall on February 1, 2026, and the FDA added it to the Enforcement Report on May 8, 2026.
The recall was initiated voluntarily by the firm, and customers were notified by letter. Distribution was international to the country of South Korea. The FDA classified the recall on May 8, 2026, and it was in the agency's weekly enforcement report on May 20, 2026.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
On-X Mitral Heart Valve with Conform-X Sewing Ring
- Model
- ONXMC-25
- UDI-DI
- 00851788001303
From the FDA notice
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of May 4, 2026
- Sold in
International distribution to the country of South Korea.
- Recalled by
- On-X Life Technologies, Inc.Austin, Texas
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 98548
- Recall number
- Z-2133-2026
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from On-X Life Technologies, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
On-X Life Technologies began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
Summary updated
