Olympus Thunderbeat II shears 35 cm may shed a distal tip component
Olympus is recalling Thunderbeat II Shears with Ultrasonic Mode, 5 mm and 35 cm, because a distal tip component may detach during use. 3,360 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a surgical instrument component may detach during use, a risk of harm with no injuries reported in the source.
Plain-English summary
Olympus is recalling the Thunderbeat II Shears with Ultrasonic Mode, 5 mm, 35 cm, model number TB2-0535FC, UDI-DI 04953170440014. The action covers 3,360 units and applies to all lot numbers.
The recall is due to the potential for detachment of a distal tip component of the device during use. The FDA classified the action as Class II.
Distribution was international, to Australia, Japan, Hong Kong and Europe. The shears are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the model number and UDI-DI above, quarantine it, and follow the instructions issued by Olympus.
The recalled product
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Surgical shears
- Affected units
- 3,360
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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