Baxter Healthcare Corporation: Medical Device Recall in 2025 - (Recall #: Z-0190-2026)

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, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code 2C8419

Product Classification:

Class II

Date Initiated: August 29, 2025

Date Posted: October 22, 2025

Recall Number: Z-0190-2026

Event ID: 97604

Reason for Recall:

IV sets may leak.

Status: Ongoing

Product Quantity: 136512

Code Information:

UDI/DI: 00085412048956,Lot Codes: R25C03055, R25C04062, and R25C29086

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