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Coloplast Manufacturing US, LLC recalls Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA612
Recalled January 22, 2025 · FDA recall Z-0844-2025 · Coloplast Manufacturing US
Hazard
A possible sterility issue was detected in Coloplast's facility on some Coloplast products. · FDA Class II
Units
226,452 units
Sold at
US Nationwide. Canada.
Description
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Product
Folysil Silicone Foley Catheters, Device Reference Numbers 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, and AA6C24.
Manufacturer(s)
Coloplast Manufacturing US, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →