Fresenius Kabi USA, LLC 2025-12-10 Health serious FDA
Health · FDA · Recall #FDA-Z-0848-2026
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. Recall
Issued December 10, 2025 · Fresenius Kabi USA, LLC
In December 2025, Fresenius Kabi USA, LLC recalled the Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004., a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
- 1 Stop using Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fresenius Kabi USA, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Fresenius Kabi USA, LLC
- Category
- Health
- Recall date
- December 10, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.
- Recall number
- FDA-Z-0848-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Fresenius Kabi USA, LLC has 16 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.