On-X Life Technologies, Inc. recalls On-X Mitral Heart Valve with Conform-X Sewing Ring
- Recalling company
- On-X Life Technologies, Inc.
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Feb 1, 2026
- Reported
- May 20, 2026
- Distribution
- International distribution to the country of South Korea.
- Status
- Ongoing
- Quantity
- 10
- Lot / codes
- UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
- Company location
- Austin, TX
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2133-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2133-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.