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Open, Classified

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.

FDA Recall Z-2142-2025 · Posted 2025-07-21

Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeKQT
Date Initiated2025-06-18
Product Quantity1 unit

Reason for Recall

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

Firm Action

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.

Root Cause

Packaging change control

Distribution Pattern

International distribution to the country of Japan.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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