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FDAAugust 6, 2025device

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 t...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential for undetected, deformed a-traumatic tips.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925043060

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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