ICU Medical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0966-2026)

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 Product No. 17003-02

Product Classification:

Class II

Date Initiated: November 24, 2025

Date Posted: December 31, 2025

Recall Number: Z-0966-2026

Event ID: 98022

Reason for Recall:

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

Status: Ongoing

Product Quantity: 12 customers

Code Information:

LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated