Recall Z-2484-2025— Olympus Corporation of the Americas

Name: FDA recall Z-2484-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-06

Class I · Ongoing

Class I FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-08-06. It names one FDA 510(k) clearance: K193517. 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: Potential for undetected, deformed a-traumatic tips..

Recalling firm: Olympus Corporation of the Americas
Classification: Class I
Status: Ongoing
Initiated: 2025-08-06
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K193517 — ViziShot 2 FLEXOlympus Surgical Technologies America·cleared 2020-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Potential for undetected, deformed a-traumatic tips.

Data sourced from openFDA. This site is unofficial and independent of the FDA.