ICU Medical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-1763-2025)

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 v2.1 and v2.2

Product Classification:

Class II

Date Initiated: May 2, 2025

Date Posted: May 21, 2025

Recall Number: Z-1763-2025

Event ID: 96771

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 12 US, 3 OUS

Code Information:

LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.

Voluntary or Mandated:

Voluntary: Firm initiated