Fresenius Kabi Recalls Ivenix Infusion System Pumps
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Fresenius Kabi USA, LLC is recalling 18,444 Ivenix Infusion System Large Volume Pumps after reports that drops or jarring can cause touchscreen malfunctions.
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 has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible. Drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior including random screen touches and/or lack of screen responsiveness.
Which Products Are Affected
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004. UDI-DI: 00811505030320. All Serial/Lot Numbers. 18,444 units distributed domestically to CA, CO, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
What You Should Do
Consumers should follow guidance from the recalling firm regarding affected devices.
Why This Matters
The Class I recall involves devices that may register unintended touch inputs at arbitrary screen locations without user interaction, which can occur intermittently.
Source
FDA recall Z-2224-2026, Fresenius Kabi USA, LLC, North Andover, MA. https://www.fda.gov
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 (1,081 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.