On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Class II- Recalling firm
- On-X Life Technologies, Inc.
- Reason for recall
- Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
- Distribution pattern
- International distribution to the country of South Korea.
- State
- TX
- Status
- Ongoing
- Recall number
- Z-2133-2026
- Recall initiated
- February 1, 2026