Olympus OER-Mini
This recall is currently active, issued December 2, 2025. It was issued by Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan.
- Recall Initiated
- October 31, 2025
- Posted
- December 2, 2025
- Recall Number
- Z-0874-2026
- Quantity
- 6578 units
- Official Source
- View on FDA website ↗
Reason for Recall
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Distribution
US Nationwide distribution.
Lot / Code Info
Model: OER-Mini; UDI: 04953170331619; Serial #: All;
Root Cause
Under Investigation by firm
Action Taken
On October 31, 2025 URGENT Medical Device Safety Alert letters were sent to customers. Actions to be taken: 1. Olympus reminds users to follow the Warnings/Cautions and inspections outlined in all Olympus Endoscope Reprocessor Operation Manuals which are important to reduce the potential risk of fire to the device. 2. Carefully read the content of the notification. 3. Check your inventory for the reference devices and identify any in your inventory. 4. Ensure all personnel are completely knowledgeable and thoroughly aware of the contents of the letter. 5. Acknowledge receipt through the provided information. 6. Forward this notice if any affected product was further distributed.