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 Product No. 17003-02
- Reason
- 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.
- 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, KY, LA, MD, MS, NY, PA, TN, VA.
- Status
- Ongoing
- Quantity
- 12 customers
- Lot / codes
- LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
- Company location
- Lake Forest, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0966-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0966-2026 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.