FDA recall, , Moderate risk
Hotline Fluid Warming Set
The Hotline Fluid Warming Set may have an increased likelihood of leakage in specific lots.
Summary by Recall Canary from the FDA notice
What happened
ICU Medical Inc. of Minneapolis, Minnesota, recalled 39,750 units of the Hotline Fluid Warming Set, List Number L-70, because of potentially inadequate solvent application at the tubing to return connector bond, which may increase the likelihood of leakage.
The 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. The company began the recall on June 24, 2026, and the FDA added it to the Enforcement Report on July 17, 2026.
The recalled product was distributed nationwide in the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Hotline Fluid Warming Set, single use device
- UDI-DI
- 30695085407007
- Lot code
- 4293568
- 4293569
- 4297510
- 4297509
- 4326087
- 4337724
- 4337725
- 4346349
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- ICU Medical Inc.Minneapolis, Minnesota
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99289
- Recall number
- Z-2759-2026
- Quantity recalled
- 39,750 units
All recalls from ICU Medical Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
