Recall Z-0872-2026 ยท FEB Accessories, Cleaning, For Endoscope
Aizu Olympus Co., Ltd.
Olympus OER-Elite
| Date | Dec 2, 2025 (initiated Oct 31, 2025) |
| Status | Open, Classified |
| Reason | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. |
| Root cause | Under Investigation by firm |
| Action | 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 provid |
| Quantity | 6578 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201920 | Endoscope Reprocessor OER-Elite Olympus Medical Systems Corp., Sep 1, 2020 |