Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Titan 0-Deg Scrotal 18 Cm Recalled by Coloplast Manufacturing US, LLC Due to A decrease in wall thickness has the potential...
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 Coloplast Manufacturing US, LLC directly.
Affected Products
Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; inflatable penile Prosthesis
Quantity: 25 units
Why Was This Recalled?
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Coloplast Manufacturing US, LLC
Coloplast Manufacturing US, LLC has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report