{"url_path":"/fda/device/recalls/Z-1972-2026","section_key":"summary","section_title":"DEVICE Recall: AVID Medical, Inc. — Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.","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-1972-2026%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":137,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-1972-2026\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 CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.\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\n1. Model Number: SHND401-04. UDI-DI (Kit Lot Numbers): 10809160395615 (1577749, 1577750, 1590780, 1590782, 1590783, 1590784, 1590785, 1590833, 1591141, 1591142, 1597561, 1600738, 1613343, 1622356, 1631890, 1643855, 1643856, 1643860, 1644853, 1645163, 1647458, 1647459, 1647460, 1650983, 1652365, 1652366).   2. Model Number: SHND401-05. UDI-DI (Kit Lot Numbers): 10809160491294 (1652367, 1668844, 1668845, 1668846, 1669188, 1669189, 1669504, 1669506, 1669507, 1671312, 1671313, 1671314, 1671315, 1671316).\n\n## Distribution\nUS distribution to FL, IL, MO, MS, NC, NE, TX."}