Recall archive / FDA device enforcement
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 — FDA record Z-2133-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 1, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- On-X Life Technologies, Inc.
- Quantity
- 10
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2133-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of South Korea.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 20, 2026
- Recall initiation date
- Feb 1, 2026
- Center classification date
- May 8, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.