Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
This recall is currently active, issued July 21, 2025. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- June 18, 2025
- Posted
- July 21, 2025
- Recall Number
- Z-2144-2025
- Quantity
- 48 units
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
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).
Distribution
International distribution to the country of Japan.
Lot / Code Info
Model Number: 194-2. UDI: 00821925002593. All lot numbers
Root Cause
Packaging change control
Action Taken
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.