LifeShield Drug Library Management (DLM), LifeShield… recallZ-1763-2025 · ICU Medical, Inc. · initiated May 2, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ICU Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software Design Change
What the company is doing
Firm began notifying consignees on May 2, 2025 via hand delivery of letters titled "Urgent Medical Device Correction." Issue 1: User receives an error if they attempt to define a Percentage Dose Change Increase limit between 60% and 99%. Customers were instructed to ensure all users or potential users of the software are made aware of the notification and proposed mitigations: Use Percentage Dose Change Increase values between 20% and 59% or between 100% and 500%. Pharmacists will not be able to use values from 60% to 99%. Issue 2: It is possible for an unauthorized user to bypass the reauthentication steps required to approve a drug library or delete a medication ruleset. Customers were instructed to ensure all users or potential users are made aware of the notification and proposed mitigation: Communicate with all users the need to log off after finishing a session before leaving the workstation and following cybersecurity best practices. ICU Medical is developing a LifeShield software update to correct both issues.
Recall details
- Recall number
- Z-1763-2025
- Status
- Open, Classified
- Initiated by the company
- May 2, 2025
- Posted by the FDA
- May 14, 2025
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 12 US, 3 OUS
- Product code
- PHC
- FDA submissions
- K223606
- 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.
Product description
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Code information (models, lots, serial numbers)
LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LifeShield Infusion Safety Software Suite - LifeShield DLM 2.1Icu Medical, Inc. · Infusion safety management software1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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