Olympus Corporation of the Americas recalled the Thunderbeat 5 mm, 35 cm, Front-Actuated Grip on October 22, 2025. The recall follows reports of adverse events associated with the device. Healthcare providers and patients must stop using this product 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, 35 cm, Front-Actuated Grip, Model No. TB-0535FC. It has been distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan. The recall affects all lots.
The Olympus Thunderbeat device poses a high risk due to continued reports of adverse events. These events could potentially lead to serious health complications.
No specific incident or injury counts have been reported in the recall data. However, the classification as a Class II recall indicates a moderate risk of adverse health consequences.
Patients and healthcare providers should stop using the Thunderbeat device immediately. Follow the recall instructions provided by Olympus Corporation for further guidance.
For more information, contact Olympus Corporation of the Americas. Visit their website or refer to the recall notification letter for detailed instructions.
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