Z-0872-2026 Class II Ongoing
FDA device recall Z-0872-2026 was initiated by Aizu Olympus Co., Ltd. on October 31, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 6578 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 10, 2025
- Initiation Date
- October 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6578 units
Product Description
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.
Distribution Pattern
US Nationwide distribution.
Code Information
Model: OER-Elite; UDI: 04953170404047; Serial #: All;