Olympus Corporation of the Americas recalled the Thunderbeat, 5 mm, 45 cm, Pistol Grip device on October 22, 2025. The recall affects 30 units distributed worldwide, including the U.S., Canada, Brazil, Germany, Mexico, and Japan. Patients and healthcare providers must stop using this device immediately due to reports of adverse events.
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 is a surgical device used for various medical procedures. Healthcare providers purchase this device for its advanced features and efficiency during surgery.
The defect in the device has led to adverse events that may compromise patient safety during surgical procedures. Immediate cessation of use is necessary to mitigate risks.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act quickly to prevent potential adverse effects from continued use of this device.
The model number and UDI can usually be found on the product packaging or the device itself.
Expect a refund processing time of 4-6 weeks after returning the device.
Keep a record of your purchase receipt, all correspondence with Olympus, and any return shipping information.
The recalled product is the Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip, Model No. TB-0545PC, with UDI: 04953170308635. The recall includes all lots of this model. The product was distributed worldwide, including the United States.
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