FDA Device recall Z-2133-2026
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 by On X Life Technologies, citing heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2133-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-01 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | On X Life Technologies |
| Distribution | n/a |
Product
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.
Identifiers
| code_info | UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409,…UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2133-2026%22
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