FDA Device recall Z-0874-2026
Olympus OER-Mini
- FDA Device
- Class II
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class II recall of Olympus OER-Mini by Aizu Olympus, citing inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0874-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-31 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Aizu Olympus |
| Distribution | US |
Product
Olympus OER-Mini
Reason
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Identifiers
| code_info | Model: OER-Mini; UDI: 04953170331619; Serial #: All; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0874-2026%22
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