Baxter Healthcare Corporation: Medical Device Recall in 2025 - (Recall #: Z-0191-2026)

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:

CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Product Code 2C8425

Product Classification:

Class II

Date Initiated: August 29, 2025

Date Posted: October 22, 2025

Recall Number: Z-0191-2026

Event ID: 97604

Reason for Recall:

IV sets may leak.

Status: Ongoing

Product Quantity: 1440

Code Information:

UDI/DI 00085412071190, Lot numbers: R25C27086

Distribution Pattern:

US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated