Olympus Corporation of the Americas Recall 95950
Description: 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: N5423730 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).
Olympus Corporation of the Americas Recall 95950 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0996-2025 |
| Event ID | 95950 |
| Event Description | 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: N5423730 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). |
| Product Type | Devices |
| Distribution | US Nationwide distribution and International: TBD. |
| Quantity | 128,608 units (OUS ONLY) |
| Recall Reason | The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. |
| Device Classification | 20250129 |
| Device Code Info | Model: TB-0535FCS; Catalog Number/Product Code: N5423730; UDI: 04953170383557, 04953170383554; Lots: All |
| Center Classification Date | 20250121 |
| Recall Initiation Date | 20241125 |
| Recalling Firm | Olympus Corporation of the Americas |
| Initial Notification | Letter |
| Similar To |