FDAHealthOctober 31, 2025

Aizu Olympus Co., Ltd. — Olympus OER-Mini

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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: October 31, 2025

US Nationwide distribution.

What's affected?

Product: Olympus OER-Mini
Brand: Aizu Olympus Co., Ltd.
Lot code: Model: OER-Mini; UDI: 04953170331619; Serial #: All;

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 6578 units.

View original FDA notice →

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