FDA recall Z-2484-2025

Olympus Corporation of the Americas · Class I · device

Product

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.

Reason for recall

Potential for undetected, deformed a-traumatic tips.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-08-06
Report date
2025-09-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2484-2025