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 Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip is a surgical device used in various medical procedures. It is designed to provide precision in surgical applications and is commonly used by healthcare professionals in operating rooms.
The device has been linked to ongoing adverse events, which raises concerns about its safety and efficacy in medical procedures. Users must stop using it immediately to avoid potential health risks.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers and patients who rely on the device for surgical procedures. Immediate cessation of use is essential to prevent possible health complications.
The model number and lot codes are typically located on the device packaging or the device itself, usually near the manufacturer's label.
Expect a refund or replacement processing timeline of approximately 4-6 weeks after your request is submitted.
Keep a record of your purchase receipt, correspondence with Olympus, and any returned items as proof of the recall.
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.
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