Coloplast Manufacturing US, LLC is recalling 262,821 units of Folysil Silicone Foley Catheters and X-Flow Prostatectomy Catheters due to potential sterility issues discovered at their facility. Sterility is critical for medical devices that enter the body, as non-sterile devices can introduce bacteria or other contaminants. The recall includes 226,452 Folysil catheters and 36,369 X-Flow catheters distributed nationwide and to specialty medical facilities. While no injuries or incidents have been reported, the company has initiated this voluntary recall to prevent potential infections.
A compromise in product sterility can lead to the introduction of harmful pathogens into the urinary tract during medical procedures. This poses a risk of serious infection or medical complications to patients.
Recalled due to possible sterility issues detected at the manufacturing facility.
Recalled due to possible sterility issues detected at the manufacturing facility.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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