FDA Medical devices recall ·
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 recall
- Recall number
- Z-2133-2026
- Date
- (initiated February 1, 2026)
- Company / brand
- On-X Life Technologies, Inc.
1300 E Anderson Ln Ste B, Austin, TX, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Why was it recalled?
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2133-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.