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Coloplast Manufacturing US, LLC recalls X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222,
Recalled January 22, 2025 · FDA recall Z-0845-2025 · Coloplast Manufacturing US
Hazard
A possible sterility issue was detected in Coloplast's facility on some Coloplast products. · FDA Class II
Units
36,369 units
Sold at
US Nationwide. Canada.
Description
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Product
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.
Manufacturer(s)
Coloplast Manufacturing US, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →