LifeShield Drug Library Management — Class II medical device recall Z-0965-2026
Ongoing recall by ICU Medical, Inc., reported 2025-12-31, distributed nationwide. For certain customers, the Change Summary review option ceases to operate as expected for any migrated library
| Recall number | Z-0965-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., Lake Forest, IL, United States |
| Recall initiated | 2025-11-24 |
| Classified | 2025-12-19 |
| Reported by FDA | 2025-12-31 |
| Distributed | Nationwide (US) |
| Quantity | 7 customers |
| UPC / GTIN / UDI-DI | 00887709127227 |
Product
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
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 changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0965-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.