FDA Enforcement
Class II
Ongoing
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.
Recall: Z-2144-2025
·
Reported July 30, 2025
Enforcement
- Recall Number
- Z-2144-2025
- Event ID
- 96982
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 30, 2025
- Initiation Date
- June 18, 2025
- Classification Date
- July 21, 2025
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
Description
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.
Reason
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Code Info
Model Number: 194-2. UDI: 00821925002593. All lot numbers
Distribution
International distribution to the country of Japan.
Quantity
48 units