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Endoscopic Aspiration Needle Recall: Olympus Removes Certain ViziShot 2 FLEX (19G) Needles Due to Potentially Deformed A-traumatic Tips

The FDA is aware that Olympus is recalling certain ViziShot 2 FLEX (19G) products due to a potential patient safety issue caused by potentially deformed a-traumatic tips. Devices manufactured before May 12, 2025, with this defect could cause hypotube component ejection and/or detached plastic components, both of which could enter the airways of the lungs (tracheobronchial tree) and require intervention for removal. 

There have been 14 reported injuries and one death related to this issue.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Questions?

Customers in the U.S. with questions about this recall should contact Olympus Customer Service at 1-800-848-9024, option 2.