United StatesOlympus Thunderbeat II Shears with Ultrasonic Mode (5 mm; 20 cm TB2-0520FC, 25 cm TB2-0525FC, 35 cm TB2-0535FC, 45 cm TB2-0545FC) are being recalled; each model’s UDI‑DI and all lot numbers were included in the recall. They were recalled because a distal tip component can detach during use.
What's being recalled
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model Number: TB2-0520FC. UDI-DI Number: 04953170439995. All Lot Numbers. Model Number: TB2-0525FC. UDI-DI: 04953170440007. All Lot Numbers. Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers. Model Number: TB2-0545FC. UDI-DI: 04953170440021. All Lot Numbers.
The hazard
Potential for detachment of a distal tip component of the device during use.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)