C.R. Bard Inc: Medical Device Recall in 2025 - (Recall #: Z-2589-2025)

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:

SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A

Product Classification:

Class II

Date Initiated: July 17, 2025

Date Posted: September 24, 2025

Recall Number: Z-2589-2025

Event ID: 97273

Reason for Recall:

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

Status: Ongoing

Product Quantity: 4,300

Code Information:

Lot#NGJX6399

Distribution Pattern:

US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.

Voluntary or Mandated:

Voluntary: Firm initiated