Olympus OER-Elite — Class II medical device recall Z-0872-2026
Ongoing recall by Aizu Olympus Co., Ltd., reported 2025-12-10, distributed nationwide. Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance
| Recall number | Z-0872-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aizu Olympus Co., Ltd., Aizuwakamatsu, Japan |
| Recall initiated | 2025-10-31 |
| Classified | 2025-12-02 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 6,578 units |
| UPC / GTIN / UDI-DI | 04953170404047 |
Product
Olympus OER-Elite
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0872-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.