# FDA recall Z-2759-2026

> **ICU Medical Inc.** · Class II · device recall initiated 2026-06-24.

## 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 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.

## Key facts

- **Recall number:** Z-2759-2026
- **Recalling firm:** ICU Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-24
- **Report date:** 2026-07-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2759-2026

## Citation

> AI Analytics. FDA recall Z-2759-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2759-2026. Source: US FDA. Licensed CC0.

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