Olympus Thunderbeat II Shears Ultrasonic Mode distal tip detachment risk
Olympus is recalling Thunderbeat II Shears (5mm, 45cm) because the distal tip component may detach during use, potentially causing patient harm.
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: The source text indicates a potential for device failure (distal tip detachment) during use with risk of harm to patients. The FDA classified this as Class II. The source does not report any actual injuries or illnesses. Under the rubric, a Class II recall involving a risk-of-harm product where injury has not yet been reported scores 3 (High).
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Thunderbeat II Shears with Ultrasonic Mode, 5mm, 45cm (Model Number: TB2-0545FC). The recall affects all lot numbers of this device.
The device has a potential for detachment of the distal tip component during use. This detachment could occur while the device is being used in medical procedures.
Affected units were distributed internationally to Australia, Japan, Hong Kong, and Europe. Healthcare facilities and users of this surgical instrument should stop using affected units immediately and contact Olympus for instructions on returns or replacement.
The recalled product
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 490
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: TB2-0545FC. UDI-DI: 04953170440021. 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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