Class II

Medical Device Recall: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

On-X Life Technologies, Inc. · February 1, 2026

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.

Distribution

International distribution to the country of South Korea.

Quantity Affected

10

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2133-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

On-X Life Technologies, Inc. Medical Device Recall: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 | SafeCheck