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 Olympus Thunderbeat is a surgical device used in minimally invasive procedures. Healthcare professionals purchase it for its advanced capabilities in cutting and coagulation.
The hazard arises from adverse events which could potentially lead to complications during surgical procedures. Users must cease use to mitigate any risks associated with these incidents.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must halt usage of this device, which may cause disruptions in surgical schedules and patient care.
Model and UDI numbers can typically be found on the packaging or directly on the device.
Expect a refund or replacement processing time of approximately 4-6 weeks after returning the device.
Keep copies of any receipts and correspondence with Olympus regarding the recall as part of your records.
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.
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