Recall Z-2759-2026— ICU Medical Inc.

Name: FDA recall Z-2759-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-24

Class II · Ongoing

Class II FDA medical device recall by ICU Medical Inc., initiated 2026-06-24. It names one FDA 510(k) clearance: K911383. 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..

Recalling firm: ICU Medical Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-06-24
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K911383 — HOTLINE FLUID WARMERLevel 1 Technologies, Inc.·cleared 1991-10-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.