FDAHealthFebruary 1, 2026
On-X Life Technologies, Inc. — On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
⚠️ Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- February 1, 2026
International distribution to the country of South Korea.
What's affected?
- Product
- On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- Lot code
- UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
Additional details
UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 10.
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