Recall archive / FDA device enforcement
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC. — FDA record Z-1851-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 23, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
- Reason
- Potential for detachment of a distal tip component of the device during use.
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 830 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1851-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: TB2-0520FC. UDI-DI Number: 04953170439995. All Lot Numbers. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 29, 2026
- Recall initiation date
- Mar 23, 2026
- Center classification date
- Apr 17, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.