Class II — ICU Medical, Inc.
| Recalling firm | ICU MEDICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 |
| Quantity | 7 customers |
| Distribution | US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA. |
| Initiated | 2025-11-24 |
| Classified | 2025-12-19 |
| Recall number | Z-0965-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ICU Medical, Inc. (Z-0965-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98000/
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