Use cautionMedical device recall · FDA · Published May 6, 2026
Fresenius Kabi Ivenix Infusion System Software Recall: False Battery Alarm Risk
Fresenius Kabi recalls Ivenix Infusion System software version 5.10.2 due to potential false battery alarms that may shut down the pump. Affected units have specific product codes and software versions.
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Take action
Contact the company
📍Recalling firmFresenius Kabi USA, LLC50 High St Ste 50 · North Andover, MA 01845-2620
“Fresenius Kabi Ivenix Infusion System Software Recall: False Battery Alarm Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49212-fresenius-kabi-ivenix-infusion-system-software-recall-false-battery-alarm. Based on FDA recall #Z-2223-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2223-2026%22&limit=1).
The FDA announced on 2026-05-06 that Fresenius Kabi USA, LLC is recalling LVP software for the Ivenix Infusion System due to a potential anomaly causing false battery readings and unexpected pump shutdowns. This voluntary Class I recall affects 32 systems distributed nationwide.
How to tell if you have it
Brand: Fresenius Kabi
Product: Ivenix Infusion System (IIS) LVP software
Product Code: LVP-SW-0005
UDI-DI: 00811505030122
Software Version: 5.10.2
The hazard
The software anomaly can cause the pump to report a false battery-health value, typically 69%, and trigger a battery-depletion alarm that shuts down the pump unless reconnected to AC mains power.
Context
GovInfoNow's records show Fresenius Kabi USA, LLC has 65 other recalls on record since 2012-09-27. Recent similar recalls include the Fresenius Kabi Tyenne Injection Recall (2026-08-10), Fresen Morphine Syringes Recall (2026-08-04), and Fresenius Kabi Glycopyrrolate Injection Recall (2026-07-16). Other recent recalls of similar products include Baxter Novum IQ Syringe Pump Recall (2026-08-11), Spectrum IQ Infusion Pump Recall (2026-01-13), and Medtronic MiniMed 780G Insulin Pump Recall (2026-05-27).
How to tell if you have this one
Check for product code LVP-SW-0005 and software version 5.10.2 on the Ivenix Infusion System. The UDI-DI number 00811505030122 also identifies affected units.
Brand
Fresenius Kabi
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your Ivenix Infusion System; affected units have version 5.10.2.
Contact Manufacturer
Reach out to Fresenius Kabi for guidance on next steps if you have the affected software version.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 21 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, 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, Missouri, Nebraska, Nevada, New Jersey, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
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-2223-2026 (May 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2223-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.