Quick Facts at a Glance
- Recall Date
- November 21, 2025
- Hazard Level
- HIGH
- Brand
- Fresenius Kabi USA
- 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
- Fresenius Kabi USA
- Product type
- Infusion System Software
- Model numbers
- Product Code: LVP-SW-0005, UDI: 00811505030122, Software versions 5.10.2 and prior.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 21, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Emphasizing instructions for LVP duration programming located in the IFU.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fresenius Kabi USA, LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
The Ivenix Infusion System is used in healthcare settings for administering intravenous medications and fluids. Healthcare providers rely on it for accurate dosing and patient care.
Why This Is Dangerous
The software issue affects the programming of LVP duration, which is critical for proper infusion management. Incorrect programming could lead to under- or over-infusion of medications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall poses a significant risk to patient safety, requiring immediate action from healthcare providers to prevent potential harm.
Practical Guidance
How to identify if yours is affected
- Verify the product code LVP-SW-0005 on the device or associated documentation.
- Check the software version against the recall details.
- Contact your healthcare provider if unsure about the software version.
Where to find product info
Check the product packaging or the device itself for labels indicating the product code and software version.
What timeline to expect
Expect a refund or replacement timeline of approximately 4-6 weeks after following recall instructions.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Contact the FDA or seek legal advice if the manufacturer does not respond.
How to prevent similar issues
- Always review recall notices for medical devices you use.
- Stay informed about updates on medical device safety from regulatory bodies.
Documentation advice
Keep records of any correspondence with the manufacturer or healthcare provider regarding the recall.
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Product Details
The recalled product is the Ivenix Infusion System LVP Software, model LVP-SW-0005. It is distributed nationwide in states including California, Florida, and Texas. This software is classified as a Class II medical device.
Key Facts
- Recall date: November 21, 2025
- Quantity recalled: 30 units
- High hazard level
- Class II medical device
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Safety Guide
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