Fresenius Kabi USA, LLC: Medical Device Recall in 2025 - (Recall #: Z-0848-2026)

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), Large Volume Pump. Model Number: LVP-0004.

Product Classification:

Class II

Date Initiated: November 3, 2025

Date Posted: December 10, 2025

Recall Number: Z-0848-2026

Event ID: 97939

Reason for Recall:

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Status: Ongoing

Product Quantity: 15,862 units

Code Information:

Model Number: LVP-0004. UDI-DI: 00811505030320.

Distribution Pattern:

US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.

Voluntary or Mandated:

Voluntary: Firm initiated