Olympus Corporation of the Americas recalled the Thunderbeat, 5 mm, 45 cm Front-Actuated Grip on October 22, 2025. The recall follows ongoing reports of adverse events associated with the device. Healthcare providers and patients must stop using the instrument 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 Front-Actuated Grip, Model No. TB-0545FC. It has worldwide distribution, including the US, Canada, Brazil, Germany, Mexico, and Japan.
The recall was initiated due to continued reports of adverse events. These events pose a significant risk to patient safety and necessitate immediate removal from use.
No specific incident numbers or details are provided. However, the classification of this recall as Class II indicates a high hazard level.
Patients and healthcare providers should stop using the device immediately. They are advised to follow instructions provided by Olympus Corporation of the Americas.
For further assistance, contact Olympus Corporation of the Americas or your healthcare provider. Additional information can be found at the FDA recall link.
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