Olympus Corporation of the Americas recalled 9,542 units of the Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S on October 22, 2025. The recall follows continued reports of adverse events associated with the device. Patients and healthcare providers must stop using it immediately and follow manufacturer 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 5 mm, 45 cm, Front-Actuated Grip Type S is a medical device used in surgical procedures. The recalled models include TB-0545FCS and several UDI numbers. The product was distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
The recall is classified as Class II, indicating a high hazard level. Adverse events reported may pose significant risks to patient safety, necessitating immediate removal from use.
The recall was initiated due to reports of adverse events; specific incident numbers are not detailed. As a result, the exact number of injuries or deaths remains unclear.
Patients and healthcare providers should stop using the Olympus Thunderbeat device immediately. Follow the recall instructions provided by Olympus and contact the manufacturer or healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas directly. Visit their website or refer to the recall notice at the FDA's website.
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