Coloplast Manufacturing US, LLC is recalling 710 units of its Ureteral Dilators (model REF RBD014) due to a possible breach in the sterile packaging detected during internal facility testing. Use of a non-sterile medical device during surgical procedures can lead to serious infections or other health complications. Consumers and healthcare providers should check their inventory for the specific lot numbers listed below. You should contact your healthcare provider or the manufacturer for further instructions regarding affected devices.
A breach in the sterile barrier of the packaging allows the device to become contaminated with environmental bacteria or pathogens. If used in a medical procedure, this contaminated device could introduce infection directly into the urinary tract of a patient.
Contact healthcare provider or manufacturer
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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