Recall Z-2484-2025 ยท KTI Bronchoscope Accessory
Olympus Corporation of the Americas
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.
| Date | Sep 5, 2025 (initiated Aug 6, 2025) |
| Status | Open, Classified |
| Reason | Potential for undetected, deformed a-traumatic tips. |
| Root cause | Process design |
| Action | 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 ad |
| Quantity | 104,508 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193517 | ViziShot 2 FLEX Olympus Surgical Technologies America, Mar 18, 2020 |