Medical Device Recall: 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 s
Olympus Corporation of the Americas · August 6, 2025
Reason for Recall
Potential for undetected, deformed a-traumatic tips.
Product Description
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Germany, Canada, Chile, China, Hong Kong, India, Japan, Singapore.
States Affected
NATIONWIDE
Quantity Affected
104,508 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2484-2025
Status: ongoing
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