Reported Jul 30, 2025 · Ongoing
Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number: CS-G7. The reusable silicone seals…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR
- Model NumberCS-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 codes and dates
- Model NumberCS-G7
- UDI-DI
0082192503833200821925001190. All lot numbers
- Amount recalled
- 41 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Why it was recalled
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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