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FDANovember 20, 2023device

OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdom...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170310355

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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