Olympus Corporation Of The Americas recalls ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The Vizi…

Potential for undetected, deformed a-traumatic tips.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2484-2025
• FDA 510(k) clearance · K193517The device's official FDA premarket clearance record
• FDA device classification · KTIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 874.4680The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.