Olympus Corporation of the Americas is recalling 363 units of the Visera Hysterovideoscope (Model HYF-V) because the Instructions for Use (IFU) are being updated. The changes include important revisions to the Ethylene Oxide (EtO) gas mixture used for sterilization and the complete removal of reusable cleaning brushes from the cleaning protocol. These updates are necessary to ensure the medical devices are properly cleaned and sterilized between uses. Consumers should contact their healthcare provider or Olympus for guidance on the updated labeling and cleaning procedures.
Incorrect sterilization or cleaning procedures, such as using the wrong gas mixture or improper brushes, can lead to inadequate disinfection of the device. This poses a potential risk of cross-contamination or infection between patients if the device is not processed according to the most current safety standards.
IFU labeling update
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.