Olympus Corporation of the Americas recalled 1,538 units of the Thunderbeat 5 mm, 10 cm, Inline Grip on October 22, 2025. The recall follows multiple reports of adverse events linked to the device. Healthcare providers and patients should stop using it immediately and follow the manufacturer's 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, 10 cm, Inline Grip is a surgical device used in various medical procedures. Surgeons typically choose this device for its ability to efficiently cut and coagulate tissue during operations.
This recall involves potential risks from adverse events related to the device's functionality. The nature of these events suggests that continued use could lead to serious complications during surgical procedures.
This recall is not part of a broader industry pattern.
The recall poses significant safety concerns for healthcare providers and patients. Immediate action is necessary to prevent potential adverse events during surgical procedures.
Model numbers are typically located on the packaging or the device itself. For surgical instruments, check near the handle or base.
Expect 4-6 weeks for refund processing after returning the device.
Keep records of your purchase, communications regarding the recall, and any medical reports related to the device's use.
The Olympus Thunderbeat 5 mm, 10 cm, Inline Grip has Model No. TB-0510IC and UDI 04953170308734. The product was distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
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