LifeShield Drug Library Management — Class II medical device recall Z-1763-2025
Ongoing recall by ICU Medical, Inc., reported 2025-05-21, distributed nationwide. Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to cr
| Recall number | Z-1763-2025 |
|---|---|
| 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 | 2025-05-02 |
| Classified | 2025-05-14 |
| Reported by FDA | 2025-05-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | PH |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00887709122802 |
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Reason for recall
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
Machine access
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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.