FDA Enforcement
Class II
Ongoing
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Recall: Z-1376-2026
·
Reported February 25, 2026
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Enforcement
- Recall Number
- Z-1376-2026
- Event ID
- 98188
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 25, 2026
- Initiation Date
- October 22, 2025
- Classification Date
- February 17, 2026
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229, United States
Description
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Reason
Firm is initiating a removal due to continued reports of adverse events.
Code Info
Lot Code: Model: TB-0520FC; UDI: 04953170370519, 04953170370502; All Lots.
Distribution
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Quantity
0 units