{"url_path":"/fda/device/recalls/Z-1942-2026","section_key":"summary","section_title":"DEVICE Recall: Ventec Life Systems, Inc. — VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-25","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1942-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Ventec Life Systems, Inc."},"word_count":163,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-1942-2026\n\n**Recalling firm:** Ventec Life Systems, Inc.\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-25\n**Report date:** 2026-05-13\n\n## Product\nVOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000\n\n## Reason\nRespiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk\n\n## Affected lots\nUDI-DI (REF/UDI-DI): PRT-01198-000/00855573007914, PRT-01185-000/00855573007877 Package/Device Serial Number (package serial number may include a \"P\" at the end): 152884, 152885, 152886, 152887, 152888, 152889, 152890, 152891, 152892, 152893, 152895, 152896, 152897, 152898, 152899, 152900, 152901, 152902, 152903, 152904, 152908, 152909, 152910, 152911, 152912, 152913, 152914, 152915, 152916, 152917, 152918, 152919, 152986, 152987, 155236, 156507, 156512, 156515, 156516, 156517, 156524, 156532\n\n## Distribution\nUS: OH, GA, CA, MO"}