Official recall notice

FDA DeviceClass IINotable

On-X Mitral Heart Valve Recall (May 2026)

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

Recall date
2026-05-20
FDA class
Class II

Why it was recalled

Hazard

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

One email a week when there are new recalls. Confirm by email; unsubscribe anytime.

Product description

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

Verify with the official notice →
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