Olympus Corporation of the Americas recalled the Thunderbeat, 5 mm, 45 cm, Pistol Grip device on October 22, 2025. The recall affects 30 units distributed worldwide, including the U.S., Canada, Brazil, Germany, Mexico, and Japan. Patients and healthcare providers must stop using this device immediately due to reports of adverse events.
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, Pistol Grip, Model No. TB-0545PC, with UDI: 04953170308635. The recall includes all lots of this model. The product was distributed worldwide, including the United States.
This recall stems from continued reports of adverse events associated with the device. These events pose a high risk to users, necessitating immediate action.
The recall does not specify the number of reported incidents or injuries. However, the designation of high hazard indicates serious potential risks.
Stop using the Olympus Thunderbeat device immediately. Patients and healthcare providers should follow the recall instructions provided in the notification letter from the manufacturer.
For more information, contact Olympus Corporation of the Americas. Visit their website or refer to the recall notification letter for further instructions.
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