USDA RECALLS AND OR UPDATES

Olympus Expands Voluntary Recall for ViziShot 2 FLEX (19G) EBUS -TBNA Needles
CENTER VALLEY, Pa., (January 16, 2026) — Olympus Corporation has announced the expansion of a previous global medical device removal action for ViziShot 2 FLEX (19G) EBUS -TBNA needles (“ViziShot 2 FLEX”) after receiving and investigating complaints of device components ejecting or detaching during procedures. The complaints included adverse event reports of patient injury and one death. This expanded action includes all lots of the ViziShot 2 FLEX needles and supersedes the August 2025 notice in which only certain lots of the device were being recalled.
Potential consequences of a detached component of the ViziShot 2 FLEX include the risk of unintended device components within the tracheobronchial tree that may require bronchoscopic extraction or surgical removal.



































