Fresenius Kabi Recalls Ivenix Infusion System LVP Software
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Fresenius Kabi USA, LLC is recalling 32 units of LVP software (Product Code LVP-SW-0005) for the Ivenix Infusion System due to a potential software anomaly causing false battery alarms and pump shutdown.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 11, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Medical Devices.
What Happened
Fresenius Kabi USA, LLC initiated a recall of the LVP software of the Ivenix Infusion System due to a 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.
Which Products Are Affected
The recall affects 32 systems of the LVP software of the Ivenix Infusion System (IIS), Product Code LVP-SW-0005, Software Version 5.10.2, UDI-DI 00811505030122. Distribution was nationwide in the United States to the states of CA, CO, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, and WI. The recall number is Z-2223-2026.
What You Should Do
Users should follow instructions provided in the firm's notification letter regarding the affected software.
Why This Matters
This Class I recall involves a device that may experience unexpected shutdown during use.
Source
FDA Recall Z-2223-2026 - Fresenius Kabi USA, LLC
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,042 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to July 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.