ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
This recall is currently active, issued September 5, 2025. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- August 6, 2025
- Posted
- September 5, 2025
- Recall Number
- Z-2484-2025
- Quantity
- 103,731 units
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for undetected, deformed a-traumatic tips.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
Lot / Code Info
Model Number: NA-U403SX-4019. UDI-DI: 00821925043060. All lots distributed between August 4, 2022 and April 25, 2025
Root Cause
Process design
Action Taken
Olympus notified consignees on about 08/06/2025 via letter. Consignees were instructed to examine inventory and quarantine any affected units, ensure all users of the device carefully read the content of this notification, including the reinforced text from the IFU and the product removal information, arrange for the return of affected units, and acknowledge receipt of the recall notification via the Olympus web portal. Consignees were also instructed to notify customers if the affected units were further distributed.