Food, drugs, devices › ICU Medical Inc.
Device recall: Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the p
ICU Medical Inc. (Minneapolis, MN) initiated this device recall on 24 Jun 2026; FDA lists 1 product record under event 99289, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. ICU Medical Inc. has 75 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
ICU Medical Inc., Minneapolis, MN.
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."
Distribution
"Worldwide - US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2759-2026 | 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 | 39,750 units | Class II | Ongoing | 29 Jul 2026 |
Context
Other enforcement events for ICU Medical Inc.
All 75 events for ICU Medical Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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 does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.