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
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
How to identify it
UPC 00851788001303
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Official source
Editorial summary by Recall Canary · last updated 2026-05-09 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification