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 Olympus Thunderbeat device is used in surgical procedures to provide cutting and coagulation functions. It is popular among healthcare providers for its efficiency and effectiveness in surgeries.
Reports of adverse events indicate potential safety issues with the device's functionality, which may compromise patient safety during procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act quickly to prevent potential health risks, making it critical to stop using the device immediately.
The model number and UDI can typically be found on the device packaging or the device itself.
Refund processing and replacement timelines may take approximately 4-6 weeks.
Keep records of any communication with Olympus and document any instances of adverse events for future reference.
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.
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