Class II recallOngoing

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — FDA event 98699

FDA · FDA event 98699 · Posted May 29, 2026

Published May 29, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Potential for the Cassette Loading Lever to break.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

Fresenius Kabi notified consignees on about 02/04/2026 via letter. Consignees were informed of the lever breakage and that two potential sources of the breakage were: 1. If the Cassette Loading Lever is left open during transport, it can be damaged if it is jarred by another object or surface. 2. Applying force to a locked Loading Lever when it is in the locked position can result in potential damage and/or cause it to break.
Consignees were reminded of proper Loading Lever handling: 1. Do not force the Cassette Loading Lever open or closed. The lever does not require significant force to operate, and excessive force can damage the LVP. Excessive force can damage the LVP and prevent use. 2. The Cassette Loading Lever does not require excessive force to load or unload the administration set. 3. If the Cassette Loading Lever does not move with minimal force, do not continue to apply force. Check that the pump is not currently infusing and verify there are no obstructions. 4. When an infusion completes or is paused, the flow dial may take up to 5 seconds to close and unlock the Cassette Loading Lever.
Consignees were also reminded of proper transport and storage to ensure the Cassette Loading Lever is fully closed prior to moving, transporting, or storing the pump, and after transport, visually confirm the Cassette Loading Lever is intact and moves freely before clinical use.
Additionally, consignees were requested to complete and return the Customer Reply Form provided.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) by Fresenius Kabi USA, LLC.

Products affected by FDA event 98699
Model	Description	Lot / serial range	Manufactured	Status
Z-2274-2026	Z-2274-2026	Model Number: LVP-0004. UDI-DI: 00811505030320	Not provided in the normalized record	Ongoing

Distribution: 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.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Feb 4, 2026
Recall initiated
Date recorded by the FDA.
May 29, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 98699
Published: May 29, 2026
Source checked: 2026-10-08 16:03:16 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

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The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — FDA event 98699

FDA · FDA event 98699 · Posted May 29, 2026

Published May 29, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) by Fresenius Kabi USA, LLC.

Products affected by FDA event 98699
Model	Description	Lot / serial range	Manufactured	Status
Z-2274-2026	Z-2274-2026	Model Number: LVP-0004. UDI-DI: 00811505030320	Not provided in the normalized record	Ongoing

Distribution

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.

Units affected

See official FDA record

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

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Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

FDA · FDA event 98872Posted Jun 5, 2026

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — FDA event 98699

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

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — FDA event 98699

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

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline