Fresenius Kabi USA, LLC: Medical Device Recall in 2025 - (Recall #: Z-2235-2025)

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:

LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.

Product Classification:

Class II

Date Initiated: June 24, 2025

Date Posted: August 6, 2025

Recall Number: Z-2235-2025

Event ID: 97165

Reason for Recall:

Potential for external cassette leaks

Status: Ongoing

Product Quantity: 348,150 units

Code Information:

Product Code: SET-0032-25. UDI-DI: 00811505030214. Lot Codes: FA24J03137, FA24J03145, FA24J07013, FA24J07021, FA24J14019, FA24J14027, FA24J21246, FA24J21253, FA24J24141, FA24J24166, FA24J28027, FA24J28035, FA24K01154, FA24K01162, FA24K11039, FA24K11047, FA24K11161, FA24K18034, FA24K18042, FA24K18059, FA24K25229, FA24L03133, FA24L09221, FA24L10203, FA24L11201, FA24L11219, FA24L16010, FA24L16028, FA24L16036, FA24L18180, FA24L19139, FA24L19147.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated