FDA Enforcement
Class II
Ongoing
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.
Recall: Z-2140-2025
·
Reported July 30, 2025
Enforcement
- Recall Number
- Z-2140-2025
- Event ID
- 96982
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Olympus Corporation of the Americas
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 30, 2025
- Initiation Date
- June 18, 2025
- Classification Date
- July 21, 2025
- Address
- 3500 Corporate Pkwy, N/A, Center Valley, PA, 18034-8229, United States
Description
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.
Reason
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Code Info
Model Number: CS-G7. UDI-DI: 00821925038332, 00821925001190. All lot numbers
Distribution
International distribution to the country of Japan.
Quantity
41 units