FDA-Device2025-01-22Class II
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.
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
36,369 units
Manufactured in
1601 W River Rd, Minneapolis, MN, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2025Don't want to check this manually?
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