Medical device recalls Moderate risk

Aizu Olympus Co., Ltd. recalls Olympus OER-Elite

Recall date
October 31, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0872-2026
FDA classification
Class II
Brand / firm
Aizu Olympus Co., Ltd.
Sold / distributed
US Nationwide distribution.

Why it was recalled

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Olympus OER-Elite

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