FDA recall, , Moderate risk
Olympus Thunderbeat II Shears w/Ultrasonic Mode
Olympus Thunderbeat II Shears w/Ultrasonic Mode may have a distal tip component that detaches during use.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, based in Center Valley, Pennsylvania, began a recall of Olympus Thunderbeat II Shears w/Ultrasonic Mode on March 23, 2026, due to the potential for detachment of a distal tip component of the device during use. The recall was added to the FDA's Enforcement Report and classified on April 17, 2026, with international distribution in Australia, Japan, Hong Kong, and Europe. The affected models include 5mm, 45cm; 5mm, 20cm; 5mm, 35cm; and 5mm, 25cm.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
4 products
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm.
- Model
- TB2-0520FC
- UDI-DI
- 04953170439995
- Lot code
- All Lot Numbers.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm.
- Model
- TB2-0525FC
- UDI-DI
- 04953170440007
- Lot code
- All Lot Numbers.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm.
- Model
- TB2-0535FC
- UDI-DI
- 04953170440014
- Lot code
- All Lot Numbers.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm.
- Model
- TB2-0545FC
- UDI-DI
- 04953170440021
- Lot code
- All Lot Numbers.
Recall details
- Company began the recall
- Sold in
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98550
- Recall numbers
- Z-1851-2026 to Z-1854-2026
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
