Fresenius Kabi USA, LLC: Medical Device Recall in 2025 - (Recall #: Z-0586-2026)

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, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.

Product Classification:

Class I

Date Initiated: November 3, 2025

Date Posted: December 10, 2025

Recall Number: Z-0586-2026

Event ID: 97941

Reason for Recall:

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

Status: Ongoing

Product Quantity: 483 cases (12,075 eaches)

Code Information:

Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.

Distribution Pattern:

US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.

Voluntary or Mandated:

Voluntary: Firm initiated