# FDA recall Z-1763-2025

> **ICU Medical, Inc.** · Class II · device recall initiated 2025-05-02.

## Product

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

## Reason for recall

Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

## Distribution

Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.

## Key facts

- **Recall number:** Z-1763-2025
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-02
- **Report date:** 2025-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1763-2025

## Citation

> AI Analytics. FDA recall Z-1763-2025. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-1763-2025. Source: US FDA. Licensed CC0.

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