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

Class II

Recalling firm: ICU Medical Inc.
Reason for recall: ICU 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.
Affected products (lot / model / serial): UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
Units affected: 39,750 units
Distribution pattern: Worldwide - US Nationwide distribution.
Firm location: Minneapolis, MN, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-2759-2026
Recall initiated: June 24, 2026
FDA classification date: July 17, 2026
FDA report date: July 29, 2026
FDA event ID: 99289
Last updated on HTM Vibe: August 4, 2026