Blue Silicone recall
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…
Why was Blue Silicone recalled?
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: CS-B612. UDI-DI: 00821925038318, 00821925001176. All lot numbers
- 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…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 19 units
- Distribution
- International distribution to the country of Japan.
- Recall date
- July 30, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)