FDADecember 8, 2023device

Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator

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

The hazard

Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170441271

Recall history

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

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