# FDA recall Z-0966-2026

> **ICU Medical, Inc.** · Class II · device recall initiated 2025-11-24.

## Product

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2    Product No. 17003-02

## Reason for recall

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

## Distribution

US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.

## Key facts

- **Recall number:** Z-0966-2026
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-24
- **Report date:** 2025-12-31

- **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-0966-2026

## Citation

> AI Analytics. FDA recall Z-0966-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0966-2026. Source: US FDA. Licensed CC0.

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