Fresenius Kabi USA, LLC: Medical Device Recall in 2026 - (Recall #: Z-1048-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 21, 2025

Date Posted: January 21, 2026

Recall Number: Z-1048-2026

Event ID: 98106

Reason for Recall:

Emphasizing instructions for LVP duration programming located in the IFU.

Status: Ongoing

Product Quantity: 30 units

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated