Quick Facts at a Glance
- Recall Date
- November 24, 2025
- Hazard Level
- HIGH
- Brand
- ICU Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ICU Medical
- Product type
- Infusion Safety Software
- Model 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.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 24, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
LifeShield Infusion Safety Software Suite v2.2 is designed to manage drug libraries for infusion pumps, ensuring safe medication delivery. Healthcare providers use it to prevent medication errors during infusion therapies.
Why This Is Dangerous
The software's malfunction prevents users from properly reviewing medication changes, which could lead to incorrect dosages being administered. This poses a significant risk to patient safety, particularly in critical care settings.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a small number of users, but those impacted may face serious risks associated with incorrect medication delivery. Immediate action is necessary to prevent potential harm.
Practical Guidance
How to identify if yours is affected
- Check if you have LifeShield Infusion Safety Software Suite v2.2 installed.
- Verify if the software was migrated from LifeShield DLM v2.1x.
- Consult the user manual to confirm the version and list number.
Where to find product info
You can find the software version and list number in the program settings or documentation provided during installation.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing or replacement.
If the manufacturer is unresponsive
- Contact ICU Medical again and request an update.
- Consider filing a complaint with the FDA if there is no response.
How to prevent similar issues
- Always check for software updates before use.
- Ensure that software has been tested for functionality after migration.
- Review user manuals for any known issues with the software.
Documentation advice
Document all communications regarding the recall, including emails and receipts for the software.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall involves LifeShield Infusion Safety Software Suite v2.2, List Number 17003-02. This software was distributed nationwide in states such as California, Iowa, Louisiana, New York, Pennsylvania, Tennessee, and Virginia. It is designed for use with infusion pumps.
Key Facts
- Recall date: November 24, 2025
- Affected software: LifeShield Infusion Safety Software Suite v2.2
- Risk of medication delivery errors
- No injuries reported
- Contact ICU Medical for instructions
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.