Quick Facts at a Glance
- Recall Date
- February 4, 2026
- Hazard Level
- HIGH
- Brand
- Fresenius Kabi USA
- Geographic Scope
- 1 states
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
- Model numbers
- Model Number: LVP-0004. UDI-DI: 00811505030320
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 4, 2026
Reported by FDA DEVICE
June 10, 2026
RecallRadar source check
June 16, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Potential for the Cassette Loading Lever to break.
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
Get instant alerts for Fresenius Kabi USA recalls
Be the first to know. Free instant alerts to your inbox.
Full Description
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.. Reason: Potential for the Cassette Loading Lever to break.. Classification: Class II. Quantity: 18,444 installed bases. Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
Get instant alerts for recalls that affect you. Free forever.