Recall Z-1853-2026 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Olympus Corporation of the Americas
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
| Date | Apr 17, 2026 (initiated Mar 23, 2026) |
| Status | Open, Classified |
| Reason | Potential for detachment of a distal tip component of the device during use. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 3,360 units |
| Distribution | International distribution in the countries of Australia, Japan, Hong Kong, and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K252150 | Ultrasonic Bipolar Generator (USG-410); Reuseable Cordless Transducer (TD-410); THUNDERBEAT II Shears with Ultrasonic Mo Olympus Medical Systems Corporation, Oct 7, 2025 |