LifeShield Drug Library Management (DLM) recallZ-0965-2026 · 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
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.
FDA root cause category: Software Design Change
What the company is doing
Firm began notifying customers on 11/24/2025 via Urgent Medical Device Correction letters. Customers were instructed to ensure all users or potential users of LifeShield ISSS DLM 2.2.1 with Plum Duo 1.1 drug libraries are made aware of the issue and the following proposed mitigations: Until a software update is released, when performing the first Plum Duo v1.1 drug library review after the migration, the pharmacist is able to review the changes using alternate review mechanisms, as noted in the LifeShield Drug Library Management User Manual: a) Accessing the version history view of the drug library b) Review drug library reports in CSV or HTML format c) Assess each change within LifeShield DLM to verify the accuracy of the changes (i.e., view impacted medication ruleset hard dose rate limit or view a CCA to verify a maximum rate setting) The firm is developing a software update to correct the issue and will notify customers of the timing of the software update.
Recall details
- Recall number
- Z-0965-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 24, 2025
- Posted by the FDA
- Dec 19, 2025
- Recalling firm
- ICU Medical, Inc.
- Quantity
- 7 customers
- Product code
- PHC
- FDA submissions
- K242117
- Distribution
- US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
Product description
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Code information (models, lots, serial numbers)
version 2.2.1 UDI-DI 00887709127227 Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.
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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