Class II

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

ICU Medical, Inc. · November 24, 2025

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.

States Affected

NATIONWIDE

Quantity Affected

7 customers

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0965-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

ICU Medical, Inc. Medical Device Recall: LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 | SafeCheck