CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

Ivenix Infusion System (IIS), LVP recalled by Fresenius Kabi USA

Fresenius Kabi USA is recalling Ivenix Infusion System (IIS), LVP, distributed nationwide in the US. The recall was initiated on 21 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.

Quantity recalled30 units

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-1048-2026
FDA event ID: 98106
Recalling firm: Fresenius Kabi USA, North Andover, MA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Nov 2025
FDA classified: 12 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

21 Nov 2025	Recall initiated by company
12 Jan 2026	Classified by FDA	+52 days
21 Jan 2026	Published in enforcement report	+9 days

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

Reason for recall

Emphasizing instructions for LVP duration programming located in the IFU.

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

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

Where it was distributed

US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.

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

Questions about this recall

Why was it recalled?

Emphasizing instructions for LVP duration programming located in the IFU.

Which lots are affected?

Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.

Where was it sold?

US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, 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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