Olympus Corporation of the Americas: 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-0535F

Hazard

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

Details from the source

Reason for recall: The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. Distribution: 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, Dominican Republic, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Guernsey, Hon Quantity: 495,865 units (96,253 US, 399,612 OUS) Lot/code info: Model Number: TB-0535FCS; Catalog Number/Product Code: R5000687; UDI: 04953170409677 and 04953170383540; Lots: All

UPC codes

04953170409677, 04953170383540

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.