The Recall Desk
ModerateFDA (Devices)·Z-2343-2023·Announced 2023-08-16

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
Category
Medical Device — Endoscope Reprocessor
Hazard
  • incompatible-device
  • sterilization
  • labeling

Distribution

Distributed nationwide across the United States.

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