Olympus Corporation of the Americas recalled the Thunderbeat surgical device on October 22, 2025, due to reports of adverse events. The recall affects 30 units distributed worldwide, including the US, Canada, and Japan. Patients and healthcare providers must stop using the device immediately.
Firm is initiating a removal due to continued reports of adverse events.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Olympus Thunderbeat, 5 mm, 45 cm Inline Grip, Model No. TB-0545IC. The device has a Unique Device Identifier (UDI) of 04953170308673. The recall affects all lots.
The recall stems from continued reports of adverse events associated with the device. The manufacturer classified this recall as Class II, indicating a potential risk that may cause reversible adverse effects.
Specific incident numbers are not disclosed, but the recall follows multiple reports of adverse events. As such, patients and healthcare providers are urged to cease use immediately.
Patients and healthcare providers should stop using the Olympus Thunderbeat device. Follow the recall instructions from Olympus Corporation of the Americas and contact your healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas at their official website or through customer service.
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