Olympus Corporation of the Americas recalls Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-…

Recall date

November 25, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0997-2025

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Do…

Why it was recalled

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423630 Software Version: N/A Product Description: Thunderbeat instrument is a sterile, single use item which is intended to be used with the Ultrasonic Generator (USG-400), the Electrosurgical Generator (WSG-400), and the Thunderbeat Transducer, (TD-TB400).