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.
Recall
- Recall Number
- Z-2139-2025
- Event Number
- 96982
- Firm
- Olympus Corporation of the Americas
- FEI Number
- 2429304
- Product Code
- HIH
- Status
- Open, Classified
- Root Cause
- Packaging change control
- Initiated
- June 18, 2025
- Posted
- July 21, 2025
- Address
- 3500 Corporate Pkwy, Center Valley, PA, 18034-8229
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.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
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.
International distribution to the country of Japan.
19 units