ICU Medical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0965-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

Product Classification:

Class II

Date Initiated: November 24, 2025

Date Posted: December 31, 2025

Recall Number: Z-0965-2026

Event ID: 98000

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.

Status: Ongoing

Product Quantity: 7 customers

Code Information:

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.

Distribution Pattern:

US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.

Voluntary or Mandated:

Voluntary: Firm initiated