FDA Medical devices recall ·
Olympus OER-Elite recall
- Recall number
- Z-0872-2026
- Date
- (initiated October 31, 2025)
- Company / brand
- Aizu Olympus Co., Ltd.
3 Chome 1-1, Aizuwakamatsu, Japan - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6578 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Olympus OER-Elite
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model: OER-Elite; UDI: 04953170404047; Serial #: All;
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0872-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.