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FDAApril 22, 2022device

EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

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

The hazard

Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170305276

Recall history

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

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