Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are co…

Recall date
June 18, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2142-2025
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
International distribution to the country of Japan.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.

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