ICU Medical, Inc. recalls LifeShield Drug Library Management
- Recalling company
- ICU Medical, Inc.
- Product
- LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 24, 2025
- Reported
- Dec 31, 2025
- Distribution
- US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
- Status
- Ongoing
- Quantity
- 7 customers
- Lot / codes
- version 2.2.1 UDI-DI 00887709127227 Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.
- Company location
- Lake Forest, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0965-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0965-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.