Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm.… recallZ-1853-2026 · Olympus Corporation of the Americas · initiated Mar 23, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for detachment of a distal tip component of the device during use.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1853-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 23, 2026
- Posted by the FDA
- Apr 17, 2026
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 3,360 units
- Product code
- GEI
- FDA submissions
- K252150
- Distribution
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
Product description
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Code information (models, lots, serial numbers)
Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 35cm TB2-0535FCOlympus Medical Systems Corp. · Electrosurgical, Cutting & Coagulation & Accessories1 recall4 reports
Other devices under the same FDA submission
3 devices cleared under K252150 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 20cm TB2-0520FCOlympus Medical Systems Corp. · Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 25cm TB2-0525FCOlympus Medical Systems Corp. · Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
- THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm TB2-0545FCOlympus Medical Systems Corp. · Electrosurgical, Cutting & Coagulation & Accessories1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 98550).
- Z-1851-2026 · Open, ClassifiedOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
- Z-1852-2026 · Open, ClassifiedOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
- Z-1854-2026 · Open, ClassifiedOlympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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