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Home › FDA recalls › Olympus Thunderbeat 5 mm
CLASS II · ModerateFDA

Olympus Corporation of the Americas recalls Olympus Thunderbeat 5 mm

📅 Oct 22, 2025 · 📍 Nationwide
Recalling company
Olympus Corporation of the Americas
Product
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Reason
Firm is initiating a removal due to continued reports of adverse events.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Oct 22, 2025
Reported
Feb 25, 2026
Distribution
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Status
Ongoing
Quantity
9,542 units
Lot / codes
Model No. TB-0545FCS; UDI: 04953170383533, 04953170383526, 04953170409684, 04953170383519; All Lots.
Company location
Center Valley, PA
Recall type
Voluntary: Firm initiated
Recall number
Z-1371-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1371-2026 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.