Class II — Potential Health Hazard

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

SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml Recalled by Medline Industries Inc Due to Loose silicone particulate was found to be present...

Date: May 28, 2019
Company: Medline Industries 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 Medline Industries Inc directly.

Affected Products

SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.

Quantity: 0

Why Was This Recalled?

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medline Industries Inc

Medline Industries Inc has 153 total recalls tracked by RecallDetector.

Related Recalls

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