Class II recallOngoing

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 recall — FDA event 98106

FDA · FDA event 98106 · Posted Jan 12, 2026

Published Jan 12, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Emphasizing instructions for LVP duration programming located in the IFU.

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

An URGENT MEDICAL DEVICE CORRECTION notification dated 11/21/25 was sent to consignees notifying them of this safety alert. The notification reiterates instructions for administering infusions included in the device's IFU. Fresenius Kabi asks consignees to disseminate the notification to all users and any facilities where devices may have been further distributed for their awareness. Consignees with any questions are to contact Customer Support by email at Ivenix_support@fresenius-kabi.com or by phone at 1-855-354-6387.

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

Affected products and models

This FDA record lists Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 by Fresenius Kabi USA, LLC.

Products affected by FDA event 98106
Model	Description	Lot / serial range	Manufactured	Status
Z-1048-2026	Z-1048-2026	Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.	Not provided in the normalized record	Ongoing

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

Timeline

Nov 21, 2025
Recall initiated
Date recorded by the FDA.
Jan 12, 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: 98106
Published: Jan 12, 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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Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 recall — FDA event 98106

FDA · FDA event 98106 · Posted Jan 12, 2026

Published Jan 12, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 by Fresenius Kabi USA, LLC.

Products affected by FDA event 98106
Model	Description	Lot / serial range	Manufactured	Status
Z-1048-2026	Z-1048-2026	Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.	Not provided in the normalized record	Ongoing

Distribution

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.

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

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 recall — FDA event 98106

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

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 recall — FDA event 98106

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

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