Recall database

Heart-Valve, Mechanical recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–1 of 1 recalls

Class IIOngoingZ-2133-2026

On-X Life Technologies, Inc. recalls On-X Mitral Heart Valve with Conform-X Sewing Ring

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

Mechanical Heart-Valve
Under Investigation by firm

On-X Life Technologies…TXMay 20, 2026