ENDOSCOPE REPROCESSOR recallZ-0872-2026 · Aizu Olympus Co., Ltd. · initiated Oct 31, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aizu Olympus Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0872-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 31, 2025
- Posted by the FDA
- Dec 2, 2025
- Recalling firm
- Aizu Olympus Co., Ltd.
- Quantity
- 6578 units
- Product code
- FEB
- FDA submissions
- K201920
- Distribution
- US Nationwide distribution.
Product description
Olympus OER-Elite
Code information (models, lots, serial numbers)
Model: OER-Elite; UDI: 04953170404047; Serial #: All;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ENDOSCOPE REPROCESSOR OER-EliteOlympus Medical Systems Corp. · Accessories, cleaning, for endoscope4 recalls323 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K201920 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- WATER FILTER MAJ-824Olympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE7 reports
- AIR FILTER MAJ-823Olympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE2 reports
- RETAINING RACK MAJ-840Olympus Medical Systems Corp. · ACCESSORIES, CLEANING, FOR ENDOSCOPE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 97849).
- Z-0873-2026 · Open, ClassifiedOlympus OER-Pro
- Z-0874-2026 · Open, ClassifiedOlympus OER-Mini
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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