Olympus Thunderbeat Surgical Instrument Recalled Due to Hazards
Olympus Corporation recalled 3,381 units of the Thunderbeat surgical instrument on October 22, 2025. The recall follows continued reports of adverse events associated with the device. Patients and healthcare providers must stop using the product immediately.
Product Details
The recalled product is the Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip, Model No. TB-0535PC. It distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.
The Hazard
The recall was initiated due to ongoing reports of adverse events linked to the use of this surgical instrument. The specific nature of these adverse events has not been disclosed.
Reported Incidents
No specific counts of injuries or deaths have been reported. The device has been classified as a Class II hazard, indicating a potential risk of serious injury.
What to Do
Patients and healthcare providers should stop using the Olympus Thunderbeat immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions.
Contact Information
For more information, contact Olympus Corporation of the Americas. Visit their website or refer to the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1378-2026.