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 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.
What is being recalled
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Why
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.
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, LA, NY, PA, TN, VA. (states named: California, Iowa, Louisiana, New York, Pennsylvania, Tennessee, Virginia)
How to tell if yours is affected
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.
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-0965-2026 |
| 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 | 7 customers |
More recalls from ICU Medical, Inc. · all medical device recalls · recalls from November 2025