On-X Life Technologies recalls

Recall found. On-X Life Technologies is named in FDA Class II recall Z-2133-2026 covering On-X Mitral Heart Valve with Conform-X Sewing Ring. Hazard: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications. Identifying details: UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17. Status: Ongoing.

Models with recalls

On-X Mitral Heart Valve with Conform-X Sewing Ring (1)

All On-X Life Technologies recalls

FDA Class II · Medical device · May 20, 2026

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

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

Official ID Z-2133-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.