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 has Model No. TB-0510IC and UDI 04953170308734. The product was distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
The recall was initiated due to continued reports of adverse events associated with the device. The exact nature of the adverse events has not been disclosed.
There are no specific incident numbers or injury counts provided in the recall notice. However, the classification of this recall as Class II indicates a high risk.
Patients and healthcare providers must stop using the Olympus Thunderbeat device. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1382-2026 or contact Olympus Corporation of the Americas directly.
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