On-X Mitral Heart Valve with Conform-X Sewing Ring — Class II medical device recall Z-2133-2026
Ongoing recall by On-X Life Technologies, Inc., reported 2026-05-20. Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed
| Recall number | Z-2133-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | On-X Life Technologies, Inc., Austin, TX, United States |
| Recall initiated | 2026-02-01 |
| Classified | 2026-05-08 |
| Reported by FDA | 2026-05-20 |
| Countries outside the US | KR |
| Quantity | 10 |
| UPC / GTIN / UDI-DI | 00851788001303 |
| Serial numbers | 2031DEC17, A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411 |
| Model numbers | ONXMC-25/33 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2133-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.