Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape Recalled by Teleflex Medical Due to The device label incorrectly states that the device...

Date: February 27, 2019
Company: Teleflex Medical
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 Teleflex Medical directly.

Affected Products

Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape, REF A1500

Quantity: 39456 devices

Why Was This Recalled?

The device label incorrectly states that the device is sterile. This product is an externally applied male condom-type catheter designed for the management of male incontinence as an alternative to incontinence pads. In normal use, the device is neither expected nor required to be sterile.

Where Was This Sold?

This product was distributed to 11 states: FL, GA, IL, ME, MA, MO, NJ, NC, OH, TX, WA

Affected (11 states)Not affected

About Teleflex Medical

Teleflex Medical has 204 total recalls tracked by RecallDetector.

Related Recalls

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