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FDAJune 18, 2025device

Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

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

The hazard

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925002593

Recall history

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

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