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CLASS II · ModerateFDA

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

📅 Oct 31, 2025 · 📍 Nationwide
Recalling company
Aizu Olympus Co., Ltd.
Product
Olympus OER-Pro
Reason
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 31, 2025
Reported
Dec 10, 2025
Distribution
US Nationwide distribution.
Status
Ongoing
Quantity
6578 units
Lot / codes
Model: OER-Pro; UDI: 04953170258589; Serial #: All;
Company location
Aizuwakamatsu
Recall type
Voluntary: Firm initiated
Recall number
Z-0873-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0873-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.