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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