On-X Mitral Heart Valve with Conform-X Sewing Ring recall (On-X Life Technologies, Inc.)
Medical deviceClass IIOngoing
Summary: On-X Life Technologies, Inc. is recalling 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.
What is being recalled
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Why
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
International distribution to the country of South Korea.
How to tell if yours is affected
UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2133-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 1, 2026 |
| Reported | May 20, 2026 |
| Company | On-X Life Technologies, Inc. |
| Company location | Austin, TX, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 10 |
More recalls from On-X Life Technologies, Inc. · all medical device recalls · recalls from February 2026