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Ivenix Infusion System Large Volume Pump
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MEDICAL DEVICE RECALLMODERATE

Ivenix Infusion System Large Volume Pump

Fresenius Kabi is recalling the Ivenix Infusion System LVP due to a risk of the cassette loading lever breaking during use.

What to do

Check the model number of your infusion pump. If you have an affected unit, contact Fresenius Kabi for further instructions regarding repair or replacement.

Recalled
Listed
Updated
Recall No.
Z-2274-2026
Agency
FDA
Firm
Fresenius Kabi USA, LLC
Recall ID
98699
Status
ONGOING

Recall at a glance

Quantity recalled
18,444 installed bases

Why it was recalled

Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (LVP) due to the potential for the cassette loading lever to break during use. A broken lever may prevent the pump from operating as intended, which could lead to an interruption in therapy.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Model
LVP-0004

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-05-30 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification