Home / Recalls / Olympus Corporation of the Americas / Z-2140-2025

Z-2140-2025 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
41 units

Product Description

Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.

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: CS-G7. UDI-DI: 00821925038332, 00821925001190. All lot numbers

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