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TGA Action ID	RC-2026-RN-00028-1
Type of Product	Medical Device
Product Name/Description	VIZISHOT 2 FLEX EBUS-TBNA NEEDLE Model: NA-U403SX-4019 SKU: R5000652 All Lot Numbers
ARTG Number	346852
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class I
Reason for the Action	Olympus received complaints for the ViziShot 2 FLEX (19G) devices in which the hypotube component ejected from the device or plastic components detached during use. Since the Recall notice in August 2025 (RC-2025-RN-00692-1) for particular lot numbers, internal investigations have identified additional contributing factors to hypotube component ejection including device heat-shrink material degradation and use errors. Additionally, investigation has identified that the device heat-shrink material (which seals the needle) degrades during clinical use and may result in difficulty in extracting or expelling samples, fluid leakage, impaired needle deployment or retraction, or breakage of device components. Potential hazards include risk of unintended device components within the tracheobroncial tree that may require intervention for removal, prolonged procedure time, mucosal injury, and bleeding, which may occur due to sharp edges or during removal of the foreign body. To mitigate these risks, Olympus is recalling all ViziShot 2 FLEX (19G) devices from the market.
Instructions for Customers/Users	Customers are to: - Inspect stock immediately and quarantine affected stock on hand to prevent further use. - Immediately cease use of ViziShot 2 FLEX (19G) devices. An Olympus representative will reach out to coordinate return of affected devices and process a credit.
Action Commencement Date	14/01/2026
Responsible Entity	Olympus Australia Pty Ltd
Contact Information	1300 132 992 - Olympus Customer Operations