Class II — Potential Health Hazard

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

BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary Recalled by C.R. Bard, Inc. Due to Labeling error: Catalog contains Instructions for Use (IFU)...

Date: December 18, 2015
Company: C.R. Bard, Inc.
Status: Terminated
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

BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Quantity: 1,428,000 units (total)

Why Was This Recalled?

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

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 51 total recalls tracked by RecallDetector.

Related Recalls

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