Lower riskMedical device recall · FDA · Published November 21, 2025
Fresenius K: Ivenix Infusion System Software LVP-SW-0005 Recall
Fresenius Kabi recalls Ivenix Infusion System software version 5.10.2 and prior due to potential LVP duration programming errors in instructions. Affected units may require software update to prevent infusion errors.
“Fresenius K: Ivenix Infusion System Software LVP-SW-0005 Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50632-fresenius-k-ivenix-infusion-system-software-lvp-sw-0005-recall. Based on FDA recall #Z-1048-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1048-2026%22&limit=1).
The FDA announced on 2025-11-21 that Fresenius Kabi USA, LLC is recalling Ivenix Infusion System (IIS) LVP Software version 5.10.2 and prior due to a hazard involving the emphasis of instructions for LVP duration programming in the IFU.
How to tell if you have it
Brand: Fresenius Kabi
Product: Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005
Product Code: LVP-SW-0005
UDI: 00811505030122
Software versions: 5.10.2 and prior
The hazard
The recall addresses the emphasis of instructions for LVP duration programming located in the IFU.
Context
GovInfoNow's records show Fresenius Kabi USA, LLC has 65 other recalls on record since 2012-09-27. Other recent recalls include Fresenius Kabi Tyenne Injection Recall: Glass Particles Hazard (2026-08-10), Fresen: Morphine Syringes May Have Wrong Labeling - Risk of Incorrect Medication (2026-08-04), and Fresenius Kabi Glycopyrrolate Injection Recall: Hair Found in Product (2026-07-16). Other recent recalls of similar products include Baxter Novum IQ Syringe Pump Recall: Software Issue May Cause Infusion Errors (2026-08-11), Fresenius 5008X Blood Tubing Set Recall: Risk of Online Port Errors (2026-05-11), and B Braun ADDitIV IV Sets Recall: Risk of Medication Backflow (2025-10-29).
How to tell if you have this one
Check if your Ivenix Infusion System has software version 5.10.2 or earlier. The product code is LVP-SW-0005, and the UDI is 00811505030122.
Brand
Fresenius Kabi
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify your Ivenix Infusion System software version; affected units have version 5.10.2 or earlier.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 20 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, Nevada, New Jersey, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1048-2026 (November 21, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1048-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.