Olympus ViziShot 2 FLEX (19G) EBUS-TBNA Needles
Olympus expands recall of all ViziShot 2 FLEX (19G) EBUS-TBNA needles due to component detachment risk, including one death.
Immediately cease use of all ViziShot 2 FLEX (19G) EBUS-TBNA needles and quarantine them. Contact the Olympus Technical Assistance Center at 1-800-848-9024, Option 1, or email complaints@olympus.com for instructions on returning the device and obtaining a replacement.
Why it was recalled
Olympus is expanding its global removal action for all lots of ViziShot 2 FLEX (19G) EBUS-TBNA needles after receiving complaints of device components ejecting or detaching during procedures, including reports of patient injury and one death. The heat-shrink material sealing the needle can degrade during clinical use, leading to difficulty extracting samples, fluid leakage, impaired needle deployment or retraction, or component breakage. Users should cease use immediately and quarantine all affected devices.
Official source
Editorial summary by Recall Canary · published 2026-01-16 · primary source: U.S. Food and Drug Administration