—#214145

Product

Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. 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.

FDA product code: HIH — Hysteroscope (And Accessories)
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K890328
Affected lot / code info: Model Number: CS-G7. UDI-DI: 00821925038332, 00821925001190. All lot numbers

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).

Root cause (FDA determination)

Packaging change control

Action the firm took

Olympus notified consignees on about 06/18/2025 via letter. Consignees were instructed to review the notification and arrange for the return of all affected units on hand, ensure all affected personnel are aware, and notify customers if the affected units were further distributed. Olympus also requested that consignees complete and return the response form acknowledging receipt of the notification.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: International distribution to the country of Japan.

Timeline

Recall initiated: 2025-06-18
Posted by FDA: 2025-07-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214145. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.