Recall Z-2139-2025— Olympus Corporation of the Americas

Name: FDA recall Z-2139-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-18

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-06-18. It names one FDA 510(k) clearance: K890328. Product: 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.. Reason: Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU)..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2025-06-18
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K890328 — ADULT RESECTOSCOPECircon Video·cleared 1990-02-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.