Recall Z-1853-2026
Olympus Corporation of the Americas · initiated March 23, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Codes / lots: Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.
Reason for recall
Potential for detachment of a distal tip component of the device during use.
FDA-determined cause: Device Design
Action taken
Olympus notified consignees on about 03/23/2026 via emailed letter. Consignees were instructed to immediately cease use of all THUNDERBEAT II devices, examine inventory for affected product and quarantine any on hand, and complete, return the Reply Form provided and arrange for the return of all affected units in inventory. Consignees were also instructed to notify other users if the affected products were transferred or further distributed.
Details
- Recall number
- Z-1853-2026
- Initiated
- March 23, 2026
- Posted by FDA
- April 17, 2026
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 3,360 units
- Distribution
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1851-2026 Class II | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.Potential for detachment of a distal tip component of the device during use. | 03/23/2026Open, Classified |
| Z-1852-2026 Class II | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.Potential for detachment of a distal tip component of the device during use. | 03/23/2026Open, Classified |
| Z-1854-2026 Class II | Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.Potential for detachment of a distal tip component of the device during use. | 03/23/2026Open, Classified |