Home / Recalls / Olympus Corporation of the Americas / Z-2144-2025

Z-2144-2025 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
July 30, 2025
Initiation Date
June 18, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48 units

Product 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 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 Pattern

International distribution to the country of Japan.

Code Information

Model Number: 194-2. UDI: 00821925002593. All lot numbers

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