FDA-Device2025-01-22Class II
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.
Coloplast Manufacturing US, LLC
Hazard
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Sold states
US Nationwide. Canada.
Affected count
226,452 units
Manufactured in
1601 W River Rd, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0844-2025Don't want to check this manually?
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