Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Recalled by C.R. Bard Inc Due to Foley catheter trays have incorrect inserts, user may...

Date: July 17, 2025
Company: C.R. Bard Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact C.R. Bard Inc directly.

Affected Products

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

Quantity: 4,300

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About C.R. Bard Inc

C.R. Bard Inc has 65 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report