Coloplast Manufacturing US, LLC recalls Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA61…

Recall date

December 2, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0844-2025

FDA classification

Class II

Brand / firm

Coloplast Manufacturing US, LLC

Sold / distributed

US Nationwide. Canada.

Why it was recalled

A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.