Fresenius Kabi Recalls Ivenix LVP-0004 Infusion Pumps

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, Devices) map to related alerts in the same area of risk - browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.