Olympus Corporation of the Americas recalled 88,268 units of the Thunderbeat surgical device on October 22, 2025. The recall follows reports of adverse events associated with the device. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.
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 device is a surgical instrument used in various medical procedures. Surgeons often rely on such devices for their precision and effectiveness in cutting and coagulating tissue during surgery.
The recall was initiated due to ongoing reports of adverse events, indicating potential safety risks associated with the device's use in medical procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the device immediately, which may disrupt scheduled surgeries and affect patient care.
Model numbers and UDI can usually be found on the device's packaging or labeling.
Expect up to 4-6 weeks for refund processing after returning the device.
Keep a copy of the recall notification letter, correspondence with the manufacturer, and any receipts related to your purchase.
The recall affects the Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S. Model numbers include TB-0535FCS, UDI: 04953170383564, 04953170383557, 04953170409677, and 04953170383540. The devices were distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
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