On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33 - Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

Source: FDA | Recall date: 05/20/2026

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

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

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

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