Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cone with Male Tubing Recalled by Olympus Corporation of the Americas Due to Discrepancies between sterilization instructions in the Japanese language...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected Products
Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Quantity: 2 units
Why Was This Recalled?
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Where Was This Sold?
International distribution to the country of Japan.
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report