# FDA recall Z-0965-2026

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

## Product

LifeShield Drug Library Management (DLM);  LifeShield Infusion Safety Software Suite v2.2    List Number 17003-02

## Reason for recall

For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

## Distribution

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

## Key facts

- **Recall number:** Z-0965-2026
- **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-0965-2026

## Citation

> AI Analytics. FDA recall Z-0965-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0965-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*