Ellik Evacuator Cone (Olympus) – Sterilization Instructions (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model Number: 191-NRS. UDI-DI: 00821925003545. All lot numbers
Products Sold
Model Number: 191-NRS. UDI-DI: 00821925003545. All lot numbers
Olympus Corporation of the Americas is recalling Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik Evacuator an due to Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Inst. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Recommended Action
Per FDA guidance
Olympus notified consignees on about 06/18/2025 via letter. Consignees were instructed to review the notification and arrange for the return of all affected units on hand, ensure all affected personnel are aware, and notify customers if the affected units were further distributed. Olympus also requested that consignees complete and return the response form acknowledging receipt of the notification.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026