ICU Medical Inc. recalls Hotline Fluid Warming Set
- Recalling company
- ICU Medical Inc.
- Product
- 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
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 24, 2026
- Reported
- Jul 29, 2026
- Distribution
- Worldwide - US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 39,750 units
- Lot / codes
- UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
- Company location
- Minneapolis, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2759-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2759-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.