Drug recall
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
FDA recall event 98000 · Class II · ICU Medical, Inc.
Key facts
| Event ID | 98000 |
|---|---|
| Recall numbers | Z-0965-2026 |
| Recalling firm | ICU Medical, Inc. |
| Product type | Devices |
| Products | LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Nov 24, 2025 |
| Report date | Dec 31, 2025 |
| City | Lake Forest |
| State | IL |
| Country | United States |
| FEI number | 3013319212 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: