Olympus Expands Voluntary Recall For Vizishot 2 Flex (19g) Ebus -tbna Needles

Recall Summary Olympus is expanding a recall of ViziShot 2 FLEX (19G) EBUS-TBNA needles, medical devices used in lung biopsies, because components can eject or detach during use. The company received complaints about this problem and is removing the devices from the market. Healthcare facilities that use these needles are affected by this expanded recall.

Recalling firm
Olympus Expands Voluntary
Product
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
Reason
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
Category
medical device recall
Country
United States
Agency
FDA-MEDWATCH-RSS
Recall date
2026-01-16
Status
Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/75ba1d97-6754-46f9-9482-d27c1695352d