LifeShield Drug Library Management recall (ICU Medical, Inc.)
Medical deviceClass IIOngoing
Summary: ICU Medical, Inc. is recalling 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.
What is being recalled
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA. (states named: California, Iowa, Kentucky, Louisiana, Maryland, Mississippi, New York, Pennsylvania, Tennessee, Virginia)
How to tell if yours is affected
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0966-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 24, 2025 |
| Reported | December 31, 2025 |
| Company | ICU Medical, Inc. |
| Company location | Lake Forest, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 12 customers |
More recalls from ICU Medical, Inc. · all medical device recalls · recalls from November 2025