Karl Storz Endoscopy has recalled 2,693 medical devices, including various Hopkins Telescopes and Nephroscopes, because their Instructions for Use (IFU) include cleaning and sterilization methods that have not been reviewed or approved for safety and efficacy by the FDA. Using unvalidated sterilization methods can result in devices that are not properly disinfected between uses. This voluntary recall affects eight specific product models distributed nationwide throughout the United States and its territories.
If medical endoscopes are reprocessed using methods that have not been validated, there is a risk that the devices may remain contaminated with biological material or pathogens from previous patients, potentially leading to healthcare-associated infections.
Information update regarding reprocessing modalities.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.