The Recall Desk
HighFDA (Devices)·Z-1854-2026·Announced 2026-04-29

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.

What this means for you

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
Category
Medical Device — Surgical Instrument
Hazard
  • device-detachment
  • component-failure

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.

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