Fresenius Kabi USA, LLC: Medical Device Recall in 2025 - (Recall #: Z-0378-2026)

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: September 3, 2025

Date Posted: November 5, 2025

Recall Number: Z-0378-2026

Event ID: 97554

Reason for Recall:

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

Status: Ongoing

Product Quantity: 6 units

Code Information:

Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.

Distribution Pattern:

US Nationwide distribution in the state of Minnesota.

Voluntary or Mandated:

Voluntary: Firm initiated