Olympus Endoscope Reprocessor OER-Mini Labeling Revised for Device Compatibility
Olympus revised labeling for the OER-Mini endoscope reprocessor. The company removed LF-V and LF-P endoscopes from the list of compatible devices and updated sterilization procedures.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving labeling clarification regarding device compatibility and sterilization procedures. No illnesses or injuries reported in the source text.
Plain-English summary
Olympus Corporation of the Americas has revised the labeling for the OER-Mini endoscope reprocessor, a device used to clean and disinfect heat-sensitive Olympus flexible endoscopes. The revision clarifies device compatibility and updates reprocessing procedures.
The updated labeling removes LF-V and LF-P endoscope models from the list of compatible devices for use with the OER-Mini. The labeling also changes the specified ethylene oxide (ETO) gas sterilization condition from 12% EtO to 100% EtO. Reusable cleaning brushes are no longer compatible with the device; single-use brushes remain an option.
Healthcare facilities and endoscopy centers using the OER-Mini should review the new labeling to ensure they follow the updated device compatibility and sterilization requirements. 241 units of the OER-Mini were distributed nationwide.
The recalled product
- Product
- Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- incompatible-device
- sterilization
- labeling
Distribution
Distributed nationwide across the United States.
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