Class I U.S. Food and Drug Administration

Fresenius Kabi USA, LLC Ivenix Infusion System , LVP Software LVP-SW-0005. Software recall: Software version 5.10.1 and earlier contain anomalies that have the potential

Recall published 10 months ago

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0885-2026
Published
December 24, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Fresenius Kabi USA, LLC
Product type
Medical devices
Units affected
30 units
Distribution
California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, Wisconsin
Made in
United States
Lot / code info
Software Versions 5.10.1 and prior; UDI: 00811505030122.

Products covered by this recall

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.

What to do about Device

Fresenius Kabi USA, LLC — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Fresenius Kabi USA, LLC — 50 High St Ste 50, North Andover, MA, 01845-2620

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Fresenius Kabi USA, LLC medical devices recalled?

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

How do I know if I have the recalled product?

The notice does not publish package codes for this recall. Compare the product name, size and the purchase window against the official FDA — Device enforcement record, and contact the company if you are unsure.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey and others.

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