Coloplast recalls Titan Touch NB Infr Zero 18cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units have specific catalog numbers and lot numbers.
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.
Coloplast is recalling certain Titan Touch NB Infr Zero 18cm inflatable penile prostheses because a decrease in wall thickness may cause premature pump failure. This could lead to the device not functioning properly during use.
The pump in the prosthesis may fail prematurely due to reduced wall thickness, which can happen after repeated inflation and deflation cycles. This could cause the device to stop working properly during use.
Men who own or use the recalled Titan Touch NB Infr Zero 18cm inflatable penile prosthesis with catalog number EN28182400 and specific lot numbers (8849570, 8904168, 8939114) are affected. Men with these devices are at risk of premature pump failure.
Check for the catalog number EN28182400 and lot numbers 8849570, 8904168, or 8939114 on the product packaging or label. The product is an inflatable penile prosthesis from Coloplast Manufacturing US, LLC.
Look for the catalog number EN28182400 and lot numbers 8849570, 8904168, or 8939114 on the product packaging or label.
The recalled product is the Titan Touch NB Infr Zero 18cm inflatable penile prosthesis with catalog number EN28182400.
Lot numbers 8849570, 8904168, and 8939114 are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1362-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1362-2023 from Coloplast. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
