Use cautionMedical device recall · FDA · Published September 8, 2022
Fresenius Kabi Ivenix Infusion System Software Version 5.2.0 May Cause Medication Flow
Fresenius Kabi recalls Ivenix Infusion System software version 5.2.0 due to potential screen freezing that can interrupt medication flow. Affected users should contact the company for updates.
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
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 Version 5.2.0 May Cause Medication Flow.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60077-fresenius-kabi-ivenix-infusion-system-software-version-5-2-0. Based on FDA recall #Z-0002-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0002-2023%22&limit=1).
Fresenius Kabi USA, LLC recalled the Ivenix Infusion System (IIS) LVP Software version 5.2.0 due to a frozen display screen that stops medication flow, according to the FDA on Sept. 8, 2022. The agency announced the Class I recall of four units distributed to New Jersey and Wisconsin.
How to tell if you have it
Brand: Fresenius Kabi
Product: Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
UDI-DI: 00811505030122 version 5.2.0
The hazard
The display screen may become frozen and unresponsive, triggering an alarm with a buzzer sound and flashing red LEDs while the screen goes blank. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
Context
GovInfoNow's records show Fresenius Kabi USA, LLC has 65 other recalls on record since Sept. 27, 2012. Other recent recalls include a Tyenne Injection recall for glass particles (Aug. 10, 2026), Morphine syringes with wrong labeling (Aug. 4, 2026), and Xylocaine 1% Injection for hair particulates (July 16, 2026). Other recent recalls of similar products include a Baxter Novum IQ Syringe Pump recall for software issues (Aug. 11, 2026), a Philips Patient Information Center iX Software freeze (July 31, 2026), and a Fresenius Medical Care 5008X CAREsystem recall for software anomalies (Oct. 25, 2025).
How to tell if you have this one
Check for the Ivenix Infusion System software version 5.2.0 (LVP-SW-0004) on your device. The recall applies to units sold with this specific software version.
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 by checking the device's display or documentation.
Contact Fresenius Kabi
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 in New Jersey and Wisconsin.
Listed by the agency
Not listed
FDA distribution: “Domestic distribution to NJ and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New Jersey, Wisconsin.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0002-2023 (September 8, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0002-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.