—#215148

Product

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.

FDA product code: KTI — Bronchoscope Accessory
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K193517
Affected lot / code info: Model Number: NA-U403SX-4019. UDI-DI: 00821925043060. Lot numbers: All lots manufactured after 7/29/2022.

Why it was recalled

Potential for undetected, deformed a-traumatic tips.

Root cause (FDA determination)

Process design

Action the firm took

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. ***Update 12/31/2025*** URGENT MEDICAL DEVICE RECALL letters were sent to additional customers on January 9, 2026 with identical instructions. ***Edit 3/23/26: January 9, 2026 letters users were instructed to return all affected devices.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.

Timeline

Recall initiated: 2025-08-06
Posted by FDA: 2025-09-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215148. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.