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FDAJune 18, 2025device

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 endo...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

0082192503831800821925001176

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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