LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
FDA Recall Z-0966-2026 · Posted 2025-12-19
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Recalling FirmICU Medical, Inc.
Recall StatusOpen, Classified
Product CodePHC
Date Initiated2025-11-24
Product Quantity12 customers
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.
Firm 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.
Root Cause
Software Design Change
Distribution Pattern
US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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