Use cautionMedical device recall · FDA · Published May 2, 2025
ICU Medical LifeShield DLM Software v2.1/v2.2: Risk of Incorrect Drug Dosing
ICU Medical recalls LifeShield Drug Library Management software versions v2.1 and v2.2 due to potential over-delivery of drugs or incorrect therapy parameters. Affected users should contact for remedy.
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.
Take action
Contact the company
📍Recalling firmICU Medical, Inc.600 N Field Dr · Lake Forest, IL 60045-4835
✎ GovInfoNow plain-language explainer
ICU Medical is recalling two versions of their LifeShield Drug Library Management software because flaws could lead to giving patients too much medication or incorrect treatment settings. This is serious for healthcare providers using the software daily. Read more at govinfonow.com/recall/52353-icu-medical-lifeshield-dlm-software-v2-1-v2-2-risk.
“ICU Medical LifeShield DLM Software v2.1/v2.2: Risk of Incorrect Drug Dosing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52353-icu-medical-lifeshield-dlm-software-v2-1-v2-2-risk. Based on FDA recall #Z-1763-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1763-2025%22&limit=1).
ICU Medical, Inc. recalled LifeShield Drug Library Management and LifeShield Infusion Safety Software Suite v2.1 and v2.2 due to software defects that may cause over-delivery of medication or incorrect therapy parameters, the FDA said on May 2, 2025.
How to tell if you have it
Brand: ICU Medical
Product: LifeShield Drug Library Management (DLM)
Product: LifeShield Infusion Safety Software Suite v2.1 and v2.2
UDI-DI: 00887709122802
The hazard
The firm identified defects in the Drug Library Management software where it does not allow users to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to a patient. Additionally, an unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Other recent recalls of similar products include the ICU Medical CADD Yellow Medication Cassette Reservoir Recall (Aug. 20, 2026), the ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and a recall regarding medical equipment and devices (June 10, 2026). Other recent recalls of similar products include the Fresenius Kabi Ivenix Infusion System Software Recall (Nov. 14, 2025).
How to tell if you have this one
Check if you have LifeShield Drug Library Management software versions v2.1 or v2.2. The product has a UDI-DI code 00887709122802.
Brand
ICU Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to ICU Medical for guidance on the remedy for affected software versions.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Iowa, Kentucky, Louisiana, Massachusetts, Mississippi, New York, Pennsylvania, Tennessee, Virginia.
Recall timeline
FDA published this recall 19 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-1763-2025 (May 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1763-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.