FDAHealthOctober 31, 2025
Aizu Olympus Co., Ltd. — Olympus OER-Pro
⚠️ 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-Pro
- Lot code
- Model: OER-Pro; UDI: 04953170258589; Serial #: All;
Additional details
Model: OER-Pro; UDI: 04953170258589; Serial #: All;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 6578 units.
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