This recall affects 7,023 Olympus TJF-Q190V duodenoscopes (EVIS EXERA III Duodenovideoscope). There have been ongoing reports of positive bacterial cultures and patient infections linked to the way these devices are cleaned and disinfected between uses. Olympus is providing updated reprocessing materials and instructions to ensure the devices are properly sanitized and to minimize errors during the cleaning process. If you have any concerns, please contact your healthcare provider or the manufacturer for more information.
Improper cleaning of these medical scopes can lead to the transmission of bacteria between patients, potentially resulting in serious infections or contamination even after the device has been processed.
Reprocessing update and instructions
Intended to be used with an Olympus video system center, light source, documentation equipment, monitor, and EndoTherapy accessories.
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.