Recall Z-1379-2026
Olympus Corporation of the Americas · initiated October 22, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Codes / lots: Model No. TB-0545IC; UDI: 04953170308673; All Lots.
Reason for recall
Firm is initiating a removal due to continued reports of adverse events.
FDA-determined cause: Under Investigation by firm
Action taken
An URGENT MEDICAL DEVICE PRODUCT REMOVAL notification was mailed to consignees on 12/22/25. The notification instructs consignees to examine inventory for affected devices, immediately cease use and quarantine devices, and contact Customer Service at 1-800-848-9024 (option 2) to obtain a Return Materials Authorization. Credit will be issued to consignees upon return of devices. If product has been further distributed, consignees are to forward the provided notification. Consginees with any questions can contact Cynthia Ow at Cynthia.Ow@Olympus.com or by phone at 674-999-3203.
Details
- Recall number
- Z-1379-2026
- Initiated
- October 22, 2025
- Posted by FDA
- February 17, 2026
- Product code
- LFL – Instrument, Ultrasonic Surgical
- Quantity
- 30 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1371-2026 Class II | Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type SFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |
| Z-1372-2026 Class II | Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type SFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |
| Z-1373-2026 Class II | Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type SFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |
| Z-1374-2026 Class II | Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated GripFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |
| Z-1375-2026 Class II | Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated GripFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |
| Z-1376-2026 Class II | Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated GripFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |
| Z-1377-2026 Class II | Olympus Thunderbeat, 5 mm, 45 cm, Pistol GripFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |
| Z-1378-2026 Class II | Olympus Thunderbeat, 5mm, 35 cm, Pistol GripFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |
| Z-1380-2026 Class II | Olympus Thunderbeat, 5 mm, 35 cm, Inline GripFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |
| Z-1381-2026 Class II | Olympus Thunderbeat, 5 mm, 20 cm, Inline GripFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |
| Z-1382-2026 Class II | Olympus Thunderbeat 5 mm, 10 cm, Inline GripFirm is initiating a removal due to continued reports of adverse events. | 10/22/2025Open, Classified |