Coloplast recalls specific Folysil Silicone Foley Catheters with Device Reference Numbers AA6106 to AA6C24 due to a possible sterility issue detected in their facility. Affected units include listed lot numbers and GTINs.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Coloplast is recalling certain Folysil Silicone Foley Catheters that may have a sterility issue. This recall involves specific product model numbers and lot numbers listed in the notice. If you own one of these items, you should check if it's affected and contact Coloplast for guidance.
The recall was initiated because a possible sterility issue was detected in Coloplast's facility for some products. This means the catheters might not be sterile, which could lead to infections if used improperly.
People who own or use the recalled Folysil Silicone Foley Catheters with the listed Device Reference Numbers and lot numbers are affected. Healthcare providers and patients using these catheters are most at risk.
Check if your catheter has a Device Reference Number listed (AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, or AA6C24). Also check the lot numbers and GTINs listed in the recall notice.
Look for the Device Reference Number and lot numbers on your catheter to see if it matches the recalled items listed in the notice.
The recall states a possible sterility issue was detected, so they may not be sterile. If you have one of the recalled items, stop using it and contact Coloplast for guidance.
Check the Device Reference Number and lot numbers on your catheter against the list provided in the recall notice.
The recall does not specify a remedy, so contact Coloplast directly for instructions on how to handle the affected product.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-0844-2025 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-0844-2025 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.
