Olympus Corporation of the Americas recalls Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy…

Recall date

June 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2139-2025

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

International distribution to the country of Japan.

Why it was recalled

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.