{"url_path":"/fda/device/recalls/Z-2133-2026","section_key":"summary","section_title":"DEVICE Recall: On-X Life Technologies, Inc. — On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-02-01","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2133-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"On-X Life Technologies, Inc."},"word_count":91,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2133-2026\n\n**Recalling firm:** On-X Life Technologies, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-02-01\n**Report date:** 2026-05-20\n\n## Product\nOn-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33\n\n## Reason\nHeart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.\n\n## Affected lots\nUDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17\n\n## Distribution\nInternational distribution to the country of South Korea."}