Z-2133-2026 Class II Ongoing
FDA device recall Z-2133-2026 was initiated by On-X Life Technologies, Inc. on February 1, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- February 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
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.
Code Information
UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17