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...
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
About Teleflex Medical
Teleflex Medical has 204 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report