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 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.
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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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