FDAHealthJune 18, 2025
Olympus Corporation of the Americas — 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
⚠️ Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- June 18, 2025
International distribution to the country of Japan.
What's affected?
- 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.
- Lot code
- s
Additional details
Model Number: CS-G7. UDI-DI: 00821925038332, 00821925001190. All lot numbers
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 41 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.