Quick Facts at a Glance
- Recall Date
- November 3, 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 Pump
- Model numbers
- Model Number: LVP-0004. UDI-DI: 00811505030320.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 3, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
December 17, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
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: E-Mail
About This Product
The Ivenix Infusion System is a large volume pump used in healthcare settings for intravenous medication delivery. It is commonly used for administering fluids and medications to patients in various clinical environments.
Why This Is Dangerous
The device may trigger alarms during low flow infusion, especially when a check valve is added, which can interrupt patient treatment and lead to potential complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the infusion system, which could disrupt medical procedures and require alternative solutions.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device. It should read LVP-0004.
- Verify if the device is part of the recalled batch by contacting the manufacturer.
- Ensure that no check valve is used in conjunction with the device.
Where to find product info
The model number and UDI-DI can usually be found on the device label or packaging.
What timeline to expect
Expect a response within 4-6 weeks regarding your recall inquiry.
If the manufacturer is unresponsive
- Follow up with the manufacturer via email or phone.
- Document all correspondence for future reference.
- Contact the FDA if issues persist.
How to prevent similar issues
- Look for infusion pumps with updated safety features.
- Check for FDA recalls regularly when purchasing medical devices.
- Consult with healthcare professionals about device reliability.
Documentation advice
Keep records of any communications with the manufacturer, receipts if available, and photographs of the device.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is the Ivenix Infusion System (IIS), Large Volume Pump, model number LVP-0004. It was distributed nationwide in states including California, Florida, and Texas. The device is classified as Class II.
Key Facts
- Model Number: LVP-0004
- Nationwide distribution in multiple states
- Immediate stop-use required
- Contact manufacturer 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.