Brand
Coloplast Manufacturing US, LLC
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Coloplast Manufacturing US, LLC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-01-22FDA-DeviceClass IIX-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.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- 2025-01-22FDA-DeviceClass IIFolysil 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.
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
- 2024-04-10FDA-DeviceClass IIUreteral dilator, REF RBD014
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 identified during testing in our facility.
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