Notice names this product. On-X Life Technologies’s On-X Mitral Heart Valve with Conform-X Sewing Ring is named in FDA Class II recall Z-2133-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported 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. Units affected: 10. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Company / brand: On-X Life Technologies recalls
Affected product: On-X Mitral Heart Valve with Conform-X Sewing Ring recall status
Official ID Z-2133-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 6:00 PM UTC.