FDAHealthOctober 22, 2025
Olympus Corporation of the Americas — Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
⚠️ Firm is initiating a removal due to continued reports of adverse events.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 22, 2025
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
What's affected?
- Product
- Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
- Lot code
- s
Additional details
Model No. TB-0535FCS; UDI: 04953170383564, 04953170383557, 04953170409677, 04953170383540; All Lots.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 88,268 units.
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