Olympus Corporation of the Americas recalled 9,542 units of the Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S on October 22, 2025. The recall follows continued reports of adverse events associated with the device. Patients and healthcare providers must stop using it immediately and follow manufacturer 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, 45 cm, Front-Actuated Grip Type S is a surgical instrument designed for use in various medical procedures. Surgeons and healthcare providers often use it to enhance precision and efficiency during operations.
The device has been linked to adverse events that may compromise patient safety. These reports prompted the recall to prevent further incidents.
This recall is not part of a broader industry pattern.
Consumers should stop using the device immediately to avoid potential health risks. The recall may cause inconvenience for healthcare providers who rely on this equipment for surgical procedures.
The model number and UDI can typically be found on the device label or in the user manual.
Expect refund processing to take approximately 4-6 weeks after returning the product.
Keep records of your purchase, any correspondence with Olympus, and photographs of the device as evidence.
The Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S is a medical device used in surgical procedures. The recalled models include TB-0545FCS and several UDI numbers. The product was distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
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