Recall Z-0965-2026— ICU Medical, Inc.

Name: FDA recall Z-0965-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-24

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2025-11-24. It names one FDA 510(k) clearance: K242117. 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..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-24
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K242117 — LifeShield Infusion Safety Software SuiteIcu Medical, Inc.·cleared 2025-04-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.