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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 241
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Same hazard · incompatible device
See all →- ModerateTerumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System
FDA (Devices) · 2018-10-31
Similar recalls
- HighEndoscope Reprocessor Tubing Assembly Error May Reduce Disinfection Effectiveness
FDA (Devices) · 2022-02-23
- HighOlympus OER-Pro Endoscope Reprocessor Recall Issued for Cleaning Instructions
FDA (Devices) · 2016-10-26
- ModerateOlympus Hysterovideoscope Labeling Revised for Sterilization Parameters and Cleaning Instructions
FDA (Devices) · 2023-09-06
- HighOlympus ENDOEYE Flex Videoscope Recalled for Reprocessing Instruction Deviations
FDA (Devices) · 2024-01-17
- HighOlympus OER-Pro reprocessor no longer compatible with two valve models
FDA (Devices) · 2026-04-01
- HighOlympus OER-Elite reprocessor no longer compatible with two valve models
FDA (Devices) · 2026-04-01