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FDAApril 18, 2024device

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

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

The hazard

The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04042761006361

Recall history

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

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