The Recall Desk
HighFDA (Devices)·Z-0966-2026·Announced 2025-12-31

Infusion software recalled over concentration limits with insufficient decimal precision

ICU Medical is recalling LifeShield Drug Library Management software because Concentration Limits can only be defined to one decimal place instead of three, which may result in over- or under-delivery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states limits set outside manufacturer recommendations may result in over- or under-delivery, and no injuries are reported.

Plain-English summary

LifeShield Drug Library Management (DLM), part of the LifeShield Infusion Safety Software Suite v2.2, product number 17003-02, is being recalled by ICU Medical, Inc.

A 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). The firm states that 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.

The record lists 12 customers, covering the LifeShield Infusion Safety Software Suite v2.2 under UDI-DI 00887709127227. Distribution was nationwide in the United States, in California, Iowa, Kentucky, Louisiana, Maryland, Mississippi, New York, Pennsylvania, Tennessee and Virginia. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Facilities should follow ICU Medical's instructions.

The recalled product

Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion software
Hazard
Affected units
12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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