Icu Medical Inc.: Warmer, Thermal, Infusion Fluid
Recall Summary ICU Medical is recalling specific lots of Hotline Fluid Warming Sets, single-use devices designed to warm blood and IV fluids for patients, due to potential leakage caused by inadequate bonding at the tubing connector. The affected devices have been distributed nationwide across all U.S. states and territories. This is a Class II recall, meaning the product could cause serious health problems or failure to perform its intended function.
- Recalling firm
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-24
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/59485140-57fe-4063-95d4-63ba896598a9