HIGH

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.

Quick Facts at a Glance

Recall Date
October 22, 2025
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Firm is initiating a removal due to continued reports of adverse events.

What You Should Do

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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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.

Key Facts

  • 140 units recalled
  • Distributed worldwide
  • Adverse events reported
  • Stop use immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
BURNOTHER

Product Classification

Product Details

Model Numbers
Model No. TB-0520IC
UDI: 04953170308581
04953170608710
All Lots.
Affected States
ALL
Report Date
February 25, 2026
Recall Status
ACTIVE

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