Olympus Corporation of the Americas: Medical Device Recall in 2025 - (Recall #: Z-2484-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: August 6, 2025

Date Posted: September 17, 2025

Recall Number: Z-2484-2025

Event ID: 97303

Reason for Recall:

Potential for undetected, deformed a-traumatic tips.

Status: Ongoing

Product Quantity: 103,731 units

Code Information:

Model Number: NA-U403SX-4019. UDI-DI: 00821925043060. All lots distributed between August 4, 2022 and April 25, 2025

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated