FDA Device recall Z-0965-2026
LifeShield Drug Library Management (DLM)
- FDA Device
- Class II
- ongoing
- Published 2025-12-31
On 2025-12-31 the FDA classified a Class II recall of LifeShield Drug Library Management (DLM) by Icu Medical, citing 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 met….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0965-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-24 |
| Published | 2025-12-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
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.
Identifiers
| code_info | version 2.2.1 UDI-DI 00887709127227 Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM…version 2.2.1 UDI-DI 00887709127227 Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration. |
|---|
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-0965-2026%22
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