FDA-Device2026-02-25Class II
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
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
3,381 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1378-2026Original summary
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip Firm is initiating a removal due to continued reports of adverse events. Model No. TB-0535PC; UDI: 04953170308659; All Lots. Distribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan. Affected quantity: 3,381 units
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