FDAFDA recall Z-2759-2026 · Jul 29, 2026
ICU Medical Inc.: Hotline Fluid Warming Set recall
Recall found
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 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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI: 30695085407007; Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
- Quantity
- 39,750 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- ICU Medical Inc., Minneapolis, MN
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-24
Source: openFDA enforcement record Z-2759-2026 · search recall number Z-2759-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.