Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
X-Flow prostatectomy catheter Recalled by Coloplast Manufacturing US, LLC Due to A possible sterility issue was detected in Coloplast's...
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
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.
Quantity: 36,369 units
Why Was This Recalled?
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
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