Coloplast Manufacturing US X-Flow prostatectomy catheter, Device Reference Numbers AB6022 recall — FDA Z-0845-2025
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Overview of recall records associated with Coloplast Manufacturing US, LLC, including dates, categories and classifications where available.
Classification mix: Class II: 3.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been…
This page summarizes recall records in which the official source identifies Coloplast Manufacturing US, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.