FDA Device recall Z-1763-2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
- FDA Device
- Class II
- ongoing
- Published 2025-05-21
On 2025-05-21 the FDA classified a Class II recall of LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 by Icu Medical, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1763-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-05-02 |
| Published | 2025-05-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Reason
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.
Identifiers
| code_info | LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1763-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.