FDA-Device2025-09-17Class I
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.
Hazard
Potential for undetected, deformed a-traumatic tips.
Sold states
Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
Affected count
104,508 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2484-2025More Olympus Corporation of the Americas recalls
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