Olympus Corporation of the Americas recalled 52 units of the Thunderbeat, 5 mm, 35 cm, Inline Grip on October 22, 2025. Reports of adverse events prompted the removal of this medical device from the market. The recall affects distribution in the US, Brazil, Canada, Germany, Mexico, and Japan.
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, 35 cm, Inline Grip, Model No. TB-0535IC, is a surgical device involved in the recall. The device has a Unique Device Identifier (UDI) of 04953170464973. It was distributed worldwide, including the US and several international markets.
The recall results from ongoing reports of adverse events associated with the device. The exact nature of these adverse events has not been detailed, but the situation presents a significant risk to patients and healthcare providers.
As of the recall date, specific incident numbers related to injuries or adverse events have not been disclosed. The high hazard level indicates serious potential risks.
Patients and healthcare providers should immediately stop using the Olympus Thunderbeat device. They should follow the recall instructions provided by Olympus Corporation of the Americas and contact their healthcare provider for further guidance.
For further assistance, consumers can contact Olympus Corporation of the Americas. More details are available on the FDA recall page at the following link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1380-2026.
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