Lower riskMedical device recall · FDA · Published November 24, 2025
ICU Medical LifeShield DLM Software v2.2: Precision Concentration Limits Issue
ICU Medical recalls LifeShield Drug Library Management software v2.2 due to concentration limit precision error. This may cause incorrect drug dosing if users adjust limits beyond manufacturer recommendations.
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.
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Contact the company
📍Recalling firmICU Medical, Inc.600 N Field Dr · Lake Forest, IL 60045-4835
✎ GovInfoNow plain-language explainer
ICU Medical is recalling LifeShield Drug Library Management software version 2.2 because it only allows concentration limits to be set to one decimal place (0.1) instead of three (0.001). This could lead to incorrect drug dosing if users change limits to match manufacturer recommendations. Read more at govinfonow.com/recall/50612-icu-medical-lifeshield-dlm-software-v2-2-precision-concentration-limits.
“ICU Medical LifeShield DLM Software v2.2: Precision Concentration Limits Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50612-icu-medical-lifeshield-dlm-software-v2-2-precision-concentration-limits. Based on FDA recall #Z-0966-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0966-2026%22&limit=1).
The FDA announced on November 24, 2025, that ICU Medical is recalling its LifeShield Drug Library Management (DLM) and LifeShield Infusion Safety Software Suite v2.2 due to a software issue that may cause incorrect medication delivery.
How to tell if you have it
LifeShield Drug Library Management (DLM), Product No. 17003-02
LifeShield Infusion Safety Software Suite v2.2, UDI-DI 00887709127227
The hazard
The software only allows Concentration Limits to be defined to one digit of precision past the decimal point instead of three digits. This limitation may require users to change limits from those recommended by the drug manufacturer, potentially resulting in over- or under-delivery of medication.
Context
GovInfoNow's records show ICU Medical has issued 60 other recalls since June 15, 2017. Other recent recalls include the CADD Yellow Medication Cassette Reservoir Recall on August 20, 2026, and the Hotline Fluid Warming Set Recall on June 24, 2026.
How to tell if you have this one
Check for LifeShield Drug Library Management (DLM) software version 2.2 with Product No. 17003-02. The software also has UDI-DI 00887709127227.
Brand
ICU Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your software version by checking the product number or UDI-DI code on the software.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Iowa, Kentucky, Louisiana, Maryland, Mississippi, New York, Pennsylvania, Tennessee, Virginia.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0966-2026 (November 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0966-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.