FDA Enforcement
Class II
Ongoing
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Recall: Z-2133-2026
·
Reported May 20, 2026
Enforcement
- Recall Number
- Z-2133-2026
- Event ID
- 98548
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- On-X Life Technologies, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 20, 2026
- Initiation Date
- February 1, 2026
- Classification Date
- May 8, 2026
- Address
- 1300 E Anderson Ln Ste B, Austin, TX, 78752-1739, United States
Description
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.
Code Info
UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
Distribution
International distribution to the country of South Korea.
Quantity
10