Olympus OER-Mini
FDA device recall Z-0874-2026 · posted 2025-12-02 · Open, Classified
Recall details
- Recalling firm
- Aizu Olympus Co., Ltd.
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FEB
- Quantity affected
- 6578 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-10-31
- Date posted
- 2025-12-02
- Location
- Aizuwakamatsu, 3 Chome, Japan
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDOSCOPE REPROCESSOR OER-MINI (K120357) | Olympus Medical Systems Corp. | 2012-12-20 |