FDA recall Z-0874-2026

Aizu Olympus Co., Ltd. · Class II · device

Product

Olympus OER-Mini

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

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2025-10-31
Report date: 2025-12-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Aizuwakamatsu, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0874-2026