Olympus Thunderbeat II TB2-0545FC Recall, Class II, 490 Units

Class 2 Device Recall Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm

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| | Class 2 Device Recall Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm | |

3500 Corporate Pkwy
Center Valley PA 18034-8229 |
| For Additional Information Contact | Cynthia Ow
647-9993203 |
| Manufacturer Reason
for Recall | Potential for detachment of a distal tip component of the device during use. |
| FDA Determined
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 in Commerce | 490 units |
| Distribution | International distribution in the countries of Australia, Japan, Hong Kong, and Europe. |
| Total Product Life Cycle | TPLC Device Report |

| 1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes. | |

| 510(K) Database | 510(K)s with Product Code = GEI |