FDA issues Class I recall for Olympus endoscope needles

Sep 24, 2025 - 03:57 PM
FDA-device-recall

The Food and Drug Administration has identified a Class I recall of certain Olympus ViziShot 2 FLEX Needles due to a possible patient safety issue caused by a potentially deformed a-traumatic tip. The notice follows a previous report on a voluntary recall issued by Olympus Sept. 22. The defect impacts products manufactured before May 12. The FDA said there have been 14 reported injuries and one death associated with the issue.

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