Olympus Corporation of the Americas: Device Recall

Recall #Z-2139-2025 · 06/18/2025

Class II: Risk

Recall Details

Recall Number
Z-2139-2025
Classification
Class II
Product Type
Device
Recalling Firm
Olympus Corporation of the Americas
Status
Ongoing
Date Initiated
06/18/2025
Location
Center Valley, PA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19 units

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).

Product Description

Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. 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.

Distribution Pattern

International distribution to the country of Japan.

Other Recalls by Olympus Corporation of the Americas

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.