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Olympus Corporation of the Americas: Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

Medical DevicesSource: FDA (device) · Date: 2026-02-25

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Reason / hazard
Firm is initiating a removal due to continued reports of adverse events.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Recall initiated
2025-10-22
Code info
Model No. TB-0535PC; UDI: 04953170308659; All Lots.
Product quantity
3,381 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
98188
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