{"url_path":"/fda/device/recalls/Z-2759-2026","section_key":"summary","section_title":"DEVICE Recall: ICU Medical Inc. — Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-24","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2759-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"ICU Medical Inc."},"word_count":116,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2759-2026\n\n**Recalling firm:** ICU Medical Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-24\n**Report date:** 2026-07-29\n\n## Product\nHotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70\n\n## Reason\nICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.\n\n## Affected lots\nUDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349\n\n## Distribution\nWorldwide - US Nationwide distribution."}