LifeShield Drug Library Management (DLM), LifeShield… recallZ-0966-2026 · ICU Medical, Inc. · initiated Nov 24, 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
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.
FDA root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-0966-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 24, 2025
- Posted by the FDA
- Dec 19, 2025
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 12 customers
- Product code
- PHC
- FDA submissions
- K242117
- Distribution
- US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.
Product description
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Code information (models, lots, serial numbers)
LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
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 17003-02ICU Medical, Inc. · Infusion safety management software2 recalls0 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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