Olympus Corporation of the Americas has issued a recall for the EVIS EXERA III Gastrointestinal Videoscope (model GIF-1TH190) involving 1,770 units. The company has determined that high-level disinfection using Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor is no longer a compatible cleaning method for this device. The manufacturer is removing this specific cleaning instruction from the product's official manual. There have been no reports of incidents or injuries related to this issue, but updated instructions are required to ensure the devices are properly disinfected between patient uses.
Using an incompatible disinfection method may result in the endoscope not being fully cleaned between procedures. This failure to achieve high-level disinfection poses a potential risk of patient-to-patient cross-contamination and the spread of infections.
HLD with Acecide-C disinfectant in the Olympus OER-Pro AER removed as a compatible reprocessing method.
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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