Z-1377-2026 Class II Ongoing
FDA device recall Z-1377-2026 was initiated by Olympus Corporation of the Americas on October 22, 2025 and is designated Class II. Reason for recall: Firm is initiating a removal due to continued reports of adverse events. The recall status is ongoing. Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 25, 2026
- Initiation Date
- October 22, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
Product Description
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Reason for Recall
Firm is initiating a removal due to continued reports of adverse events.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
Code Information
Model No. TB-0545PC; UDI: 04953170308635; All Lots.