Olympus Corporation of the Americas recalls ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is…

Recall date

August 6, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2484-2025

FDA classification

Class I

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

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

Why it was recalled

Potential for undetected, deformed a-traumatic tips.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.