FDAClass IIDecember 10, 2025

Olympus OER-Mini recall

Olympus OER-Mini

Why was Olympus OER-Mini recalled?

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model: OER-Mini; UDI: 04953170331619; Serial #: All;

Product
Olympus OER-Mini
Recalling firm
Aizu Olympus Co., Ltd.
Quantity
6578 units
Distribution
US Nationwide distribution.
Recall date
December 10, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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