FDA recall, Company announced Jan 16, 2026

Olympus ViziShot 2 FLEX (19G) EBUS -TBNA Needles

ViziShot 2 Flex needles can eject or detach components during procedures, risking patient injury or death.

Summary by Recall Canary from the FDA notice

Olympus Corporation has expanded a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles after receiving complaints of device components ejecting or detaching during procedures, including adverse event reports of patient injury and one death.

This expanded action includes all lots of the needles and supersedes the August 2025 notice that covered only certain lots. Potential consequences of a detached component include the risk of unintended device components within the tracheobronchial tree that may require bronchoscopic extraction or surgical removal.

Internal investigations identified additional contributing factors including device heat-shrink material degradation and use errors, which affect all lots. The heat-shrink material can degrade during clinical use and may result in difficulty extracting or expelling samples, fluid leakage, impaired needle deployment or retraction, or breakage of device components.

What to do

If you have this product:

Customers have been instructed to return the affected devices to Olympus by following the instructions provided in the removal action communication.
For information on how to identify affected product, U.S. customers can contact the Olympus Technical Assistance Center (TAC) at 1-800-848-9024, Option 1, Monday-Friday between 7:00 AM and 8:00 PM ET.
Users are directed to cease use immediately and quarantine all ViziShot 2 FLEX devices.