Olympus Corporation of the Americas recalled 4,181 units of its Thunderbeat surgical device on October 22, 2025. Reports of adverse events prompted the removal of this device. The recall affects devices distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
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 recall involves the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S, Model No. TB-0520FCS. The devices were sold in multiple countries, including the US, from an unspecified date.
The Olympus Thunderbeat device has been linked to reports of adverse events that pose significant risks to patients. As a Class II recall, the potential for serious injury is high, necessitating immediate action.
There are ongoing reports of adverse events associated with this device. Specific numbers regarding injuries or incidents were not disclosed.
Stop using the Olympus Thunderbeat device immediately. Contact your healthcare provider or Olympus Corporation of the Americas for further instructions.
For more information, call Olympus Corporation of the Americas or visit their website. Recall notifications will be sent via letter.
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