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FDAJune 18, 2025device

Glass Body For 194 Ellik Evacuator. Model Number: 190A. 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

00821925003538

Recall history

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

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Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths. — Recall Details · AllClear