Olympus Corporation of the Americas: Medical Device Recall in 2025 - (Recall #: Z-2139-2025)
See the recall detail below. You can also see other recalls from the same firm in 2025.
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.
Class II
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Model Number: CS-B612. UDI-DI: 00821925038318, 00821925001176. All lot numbers
International distribution to the country of Japan.
Voluntary: Firm initiated
