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
- Software Suite
- Model numbers
- LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227
- 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
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.
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 used in healthcare settings to manage drug concentrations during infusion treatments. It is essential for ensuring accurate drug delivery to patients.
Why This Is Dangerous
The software's limitation to one decimal place for concentration limits may force healthcare providers to alter dosing recommendations, leading to incorrect medication administration.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires immediate attention from healthcare providers to prevent potential dosage errors, which could affect patient safety.
Practical Guidance
How to identify if yours is affected
- Check the model number of your software to see if it matches LifeShield Infusion Safety Software Suite v2.2.
- Verify the software version to confirm if it is affected by the recall.
- Review any communication from ICU Medical regarding the recall.
Where to find product info
You can find the model number on the software interface or in the product documentation provided by ICU Medical.
What timeline to expect
Expect a response regarding the recall and any potential refunds within 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with ICU Medical regarding the recall.
- Follow up with ICU Medical if you do not receive a timely response.
How to prevent similar issues
- When purchasing medical software, ensure it meets current safety standards.
- Look for software with verified precision and accuracy in drug dosing.
- Always stay informed about product recalls and safety notices.
Documentation advice
Keep records of your software purchase, correspondence with ICU Medical, and any relevant documentation related to the recall.
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Product Details
Product Name: LifeShield Infusion Safety Software Suite v2.2. Model Number: 17003-02. Quantity: 12 units distributed nationwide in California, Iowa, Kentucky, Louisiana, Maryland, Mississippi, New York, Pennsylvania, Tennessee, and Virginia.
Key Facts
- Recall Date: November 24, 2025
- Report Date: December 31, 2025
- Classification: Class II
- Affected States: CA, IA, KY, LA, MD, MS, NY, PA, TN, VA
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Safety Guide
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