CLASS II ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recalled

Fresenius Kabi USA is recalling The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS), distributed nationwide in the US. The recall was initiated on 4 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: LVP-0004. UDI-DI: 00811505030320

Quantity recalled18,444 installed bases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2274-2026
FDA event ID: 98699
Recalling firm: Fresenius Kabi USA, North Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Feb 2026
FDA classified: 29 May 2026
Reported: 10 Jun 2026
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

4 Feb 2026	Recall initiated by company
29 May 2026	Classified by FDA	+114 days
10 Jun 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for the Cassette Loading Lever to break.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

Where it was distributed

US Nationwide distribution 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, WI.

Nationwide California Colorado Florida Georgia Idaho Illinois Massachusetts Maryland Maine Michigan Minnesota Mississippi Nebraska New Jersey Nevada Oklahoma Oregon South Carolina Texas Virginia

Questions about this recall

Why was it recalled?

Potential for the Cassette Loading Lever to break.

Which lots are affected?

Model Number: LVP-0004. UDI-DI: 00811505030320

Where was it sold?

US Nationwide distribution 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, WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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