FDAHealthJune 18, 2025
Olympus Corporation of the Americas — 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 w
⚠️ 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
- 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.
- Lot code
- s
Additional details
Model Number: CS-B612. UDI-DI: 00821925038318, 00821925001176. All lot numbers
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 19 units.
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