Lower riskMedical device recall · FDA · Published November 24, 2025
ICU Medical LifeShield Drug Library Management v2.2.1 recall: Migration issues cause
ICU Medical recalls LifeShield Drug Library Management v2.2.1 for migration issues that may cause infusion pump delivery errors. Affected users must use alternate methods to review changes after migration.
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
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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 2.2.1 because some users may experience delivery errors with infusion pumps after migrating from an older version. This happens if the software stops properly reviewing changes to drug libraries. Read more at govinfonow.com/recall/50609-icu-medical-lifeshield-drug-library-management-v2-2-1-recall.
“ICU Medical LifeShield Drug Library Management v2.2.1 recall: Migration issues cause.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50609-icu-medical-lifeshield-drug-library-management-v2-2-1-recall. Based on FDA recall #Z-0965-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0965-2026%22&limit=1).
The FDA announced on Nov. 24, 2025, that ICU Medical, Inc. is recalling LifeShield Drug Library Management and LifeShield Infusion Safety Software Suite v2.2 due to a software defect. The hazard involves the Change Summary review option ceasing to operate as expected for migrated libraries, potentially leading to infusion pump delivery errors.
How to tell if you have it
Brand: ICU Medical
Product: LifeShield Drug Library Management (DLM)
Product: LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Version: 2.2.1
UDI-DI: 00887709127227
Affected customers: 7
The hazard
According to the FDA, for certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since 2017-06-15. Other recent recalls of similar products include Baxter Novum IQ Syringe Pump Recall (2026-08-11), Fresenius Kabi Ivenix Infusion System Software Recall (2025-11-14), and B Braun Medical Outlook IV Set Recall (2025-10-29).
How to tell if you have this one
Check if you migrated from LifeShield DLM v2.1x to v2.2.1 and have a Plum Duo v1.1 drug library that was approved or locked for review before the migration. The software version is 2.2.1 with 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 if you migrated from LifeShield DLM v2.1x to v2.2.1 and have a Plum Duo v1.1 drug library approved or locked for review before migration.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, IA, LA, 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, Louisiana, 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-0965-2026 (November 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0965-2026 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.