Olympus Corporation of the Americas recalled the Thunderbeat 5 mm, 20 cm, Front-Actuated Grip on October 22, 2025. The recall follows ongoing reports of adverse events associated with the medical device. Patients and healthcare providers must stop using the device immediately and follow recall 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 recalled product is the Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip, with model number TB-0520FC. It has a Unique Device Identifier (UDI) of 04953170370519 and additional UDI of 04953170370502. The device was distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
The recall stems from continued reports of adverse events linked to the Olympus Thunderbeat device. The specific nature of these adverse events remains undisclosed, but they pose a high hazard level to users.
The recall does not specify the number of reported incidents or injuries. However, the classification as a Class II recall indicates a high risk of serious injury or adverse health consequences.
Patients and healthcare providers should stop using the Olympus Thunderbeat device immediately. They should follow the recall instructions provided by the manufacturer and contact Olympus Corporation of the Americas for further instructions.
For more information, patients and healthcare providers can visit the Olympus Corporation of the Americas website or contact them directly. Additional details are available at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1376-2026.
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