Use caution Medical device recall · FDA · Published June 24, 2026

ICU Medical Hotline Fluid Warming Set Recall: Leakage Risk in Specific Lots

ICU Medical recalls specific lots of Hotline Fluid Warming Sets due to potential leakage. Affected units may cause fluid leaks during medical use. Contact for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2759-2026Medical device ICU Medical ›

Use caution until it’s fixed

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.

✎ GovInfoNow plain-language explainer

ICU Medical is recalling specific lots of Hotline Fluid Warming Sets because they may leak. This could lead to improper fluid delivery during medical procedures, posing a risk to patient safety. Read more at govinfonow.com/recall/127765-icu-medical-hotline-fluid-warming-set-recall-leakage-risk-in.

Source Summary by GovInfoNow · govinfonow.com/recall/127765-icu-medical-hotline-fluid-warming-set-recall-leakage-risk-in · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2759-2026

Cite this page

“ICU Medical Hotline Fluid Warming Set Recall: Leakage Risk in Specific Lots.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127765-icu-medical-hotline-fluid-warming-set-recall-leakage-risk-in. Based on FDA recall #Z-2759-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2759-2026%22&limit=1).

ICU Medical Inc. recalled Hotline Fluid Warming Sets on June 24, 2026, due to leakage risks from inadequate solvent application at the tubing-to-connector bond, according to the FDA. The voluntary Class II recall affects 39,750 units distributed nationwide in the U.S.

How to tell if you have it

Brand: ICU Medical
Product: Hotline Fluid Warming Set (single use device)
List Number: L-70
UDI-DI: 30695085407007
Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349
Distribution: US Nationwide

The hazard

ICU Medical identified an increased likelihood of leakage in specific lots due to potentially inadequate solvent application at the tubing to return connector bond. The device is designed to warm blood and intravenous fluids under gravity flow conditions.

Context

GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Recent brand recalls include the August 20, 2026 CADD Yellow Medication Cassette Reservoir Recall for leakage risk and the May 12, 2026 IV Sets recall regarding black specks in drip chambers. Other recent recalls of similar products include Medline Medical Kits Recall: Particulate in Fluid Path Risk (March 24, 2026) and Medline medical procedure kits with Strykeflow 2 irrigation leak risk (December 16, 2025).

How to tell if you have this one

Check for Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349. The device is a single-use medical device for warming blood and IV fluids.

Brand
ICU Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Identify if your device has one of the affected Lot Numbers: 4293568, 4293569, 4297510, 4297509, 4326087, 4337724, 4337725, 4346349.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 35 days after the firm started it.

Jun 24, 2026Firm started the recall
Jul 17, 2026FDA classified it Class II
Jul 29, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More ICU Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/127765-icu-medical-hotline-fluid-warming-set-recall-leakage-risk-in">ICU Medical Hotline Fluid Warming Set Recall: Leakage Risk in Specific Lots (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2759-2026 (June 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2759-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.