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FDAApril 18, 2023device

Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

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

The hazard

The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170403019

Recall history

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

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Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100 — Recall Details · AllClear