On-X Mitral Heart Valve with Conform-X Sewing Ring
On-X is recalling Model ONXMC-25/33 Mitral Heart Valve due to incomplete testing before distribution.
If you have received an On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33, contact your healthcare provider or cardiologist immediately to discuss whether your valve may be affected and what follow-up care or monitoring may be necessary.
Why it was recalled
On-X Life Technologies is recalling the On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33, because units were released and distributed before all required testing was complete, and it cannot be confirmed that they meet all release specifications. Patients who have received this valve should contact their healthcare provider immediately.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
On-X Mitral Heart Valve with Conform-X Sewing Ring
- Model
- ONXMC-25
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-05-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification