Fresenius Kabi USA, LLC: Medical Device Recall in 2025 - (Recall #: Z-0885-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: November 14, 2025

Date Posted: December 24, 2025

Recall Number: Z-0885-2026

Event ID: 98009

Reason for Recall:

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

Status: Ongoing

Product Quantity: 30 units

Code Information:

Software Versions 5.10.1 and prior; UDI: 00811505030122.

Distribution Pattern:

US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.

Voluntary or Mandated:

Voluntary: Firm initiated