{"url_path":"/fda/device/recalls/Z-1975-2026","section_key":"summary","section_title":"DEVICE Recall: AVID Medical, Inc. — Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-13","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1975-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"AVID Medical, Inc."},"word_count":101,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-1975-2026\n\n**Recalling firm:** AVID Medical, Inc.\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-13\n**Report date:** 2026-05-13\n\n## Product\nHalyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.\n\n## Reason\nPotential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.\n\n## Affected lots\nModel Number: SELF131-05. UDI-DI (Kit Lot Numbers): 10809160408650 (1611688, 1611689, 1618351, 1621441, 1627930, 1635908, 1644501, 1646021, 1651957, 1654887, 1656582, 1656581, 1659713, 1670884, 1670885, 1671950).\n\n## Distribution\nUS distribution to FL, IL, MO, MS, NC, NE, TX."}