FDAFDA · Food and drugs·Recall number Z-1854-2026
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Published April 29, 2026 · Recall initiated: March 23, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for detachment of a distal tip component of the device during use.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- Lot
- Model Number: TB2-0545FC. UDI-DI: 04953170440021. All Lot Numbers.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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