Class 2 Device Recall LifeShield Infusion Safety Software Suite v2.2

• Date Initiated by Firm: November 24, 2025
• Date Posted: December 19, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0966-2026
• Recall Event ID: 98022
• 510(K)Number: K242117
• Product Classification: Infusion safety management software - Product Code PHC
• Product: LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
• Code Information: LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
• Recalling Firm/ Manufacturer: ICU Medical, Inc.; 600 N Field Dr; Lake Forest IL 60045-4835
• For Additional Information Contact: Technical Support; 800-241-4002 Ext. 3
• Manufacturer 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.
• FDA Determined Cause: Software Design Change
• Action: On November 24, 2025, the firm notified customers via Urgent Medical Device Correction letters. Consignees were asked to take the following actions: 1. Ensure all users or potential users of LifeShield DLM 2.2.1 are immediately made aware of this notification and proposed mitigations. 2. Until a software update is released, limit any newly created or edited Concentration Limits to one decimal place of precision for limits less than 100. ICU Medical is developing a software update to correct this issue and will notify customers of the timing of the software update.
• Quantity in Commerce: 12 customers
• Distribution: US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = PHC