FDA-Device2026-02-25Class II
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Olympus Corporation of the Americas
Hazard
Firm is initiating a removal due to continued reports of adverse events.
Sold states
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Affected count
88,268 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1372-2026Original summary
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S Firm is initiating a removal due to continued reports of adverse events. Model No. TB-0535FCS; UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540; All Lots. Distribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan. Affected quantity: 88,268 units
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