FDA DevicesClass II
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Published: May 20, 2026Recall ID: Z-2133-2026Category: devicesCountry: US
Reason for Recall / Hazard
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Product Description & Identification
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Additional Source Details
| Field | Value |
|---|---|
| City | Austin |
| State | TX |
| Event id | 98548 |
| Address 1 | 1300 E Anderson Ln Ste B |
| Code info | UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17 |
| Postal code | 78752-1739 |
| Report date | 20260520 |
| Product type | Devices |
| Product quantity | 10 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260201 |
| Initial firm notification | Letter |
| Center classification date | 20260508 |
Overview
- Recalling FirmOn-X Life Technologies, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionInternational distribution to the country of South Korea.