Fresenius Kabi Recalls Ivenix LVP-0004 Infusion Pumps
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Fresenius Kabi USA, LLC is recalling 18,444 units of the Large Volume Pump (LVP) of the Ivenix Infusion System due to potential breakage of the Cassette Loading Lever.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 10, 2026 and geographically references United States. Its severity classification of "medium" 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, Devices.
What Happened
Fresenius Kabi USA, LLC initiated a voluntary recall of the Large Volume Pump (LVP) of the Ivenix Infusion System because of the potential for the Cassette Loading Lever to break.
Which Products Are Affected
The affected product is the Large Volume Pump (LVP) of the Ivenix Infusion System (IIS), Model Number: LVP-0004. UDI-DI: 00811505030320. A total of 18,444 installed bases are affected. Distribution occurred nationwide in the United States, specifically in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, and WI. The recall number is Z-2274-2026.
What You Should Do
Consumers with questions should contact the recalling firm.
Why This Matters
This Class II recall involves a device distributed across multiple states with a potential mechanical failure that could affect infusion delivery.
Source
FDA Recall Z-2274-2026 - 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 (958 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 10, 2026.
Frequently Asked Questions
Common questions about this FDA recall.