FDAFDA · Food and drugs·Recall number Z-2133-2026
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Published May 20, 2026 · Recall initiated: February 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- On-X Life Technologies, Inc.
- Distributor
- International distribution to the country of South Korea.
- Lot
- UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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