← FDA ENFORCEMENT
Z-0874-2026Class II
Aizu Olympus Co., Ltd.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Aizu Olympus Co., Ltd.
Product type
Device
Status
Ongoing
Report date
2025-12-10
Distribution
US Nationwide distribution.
Product quantity
6578 units
Initiated by
Voluntary: Firm initiated
Reason for recall
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Product description
Olympus OER-Mini
Code / lot info
Model: OER-Mini; UDI: 04953170331619; Serial #: All;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →