Olympus Thunderbeat Surgical Device Recalled Due to Adverse Events
Olympus Corporation of the Americas recalled 140 units of its Thunderbeat surgical device on October 22, 2025. Users reported ongoing adverse events linked to the device. Healthcare providers should stop using it immediately and follow recall instructions.
Product Details
The Olympus Thunderbeat is a 5 mm, 20 cm surgical device. It is identified by model numbers TB-0520IC and UDI: 04953170308581. The product was distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
The Hazard
The Olympus Thunderbeat poses a high risk due to reports of adverse events. Specific details about the nature of these adverse events are not disclosed.
Reported Incidents
The recall follows continued reports of adverse events, but specific injury or incident counts are not provided, indicating a potential serious risk.
What to Do
Stop using the Olympus Thunderbeat surgical device immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions and follow the recall procedures outlined in the notification letter.
Contact Information
For more information, contact Olympus Corporation of the Americas at [insert contact number] or visit their website. You can also refer to the FDA notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1381-2026.