Olympus endoscope seals recalled for sterilization instruction discrepancy
Olympus Corporation recalls 41 Green Silicone Seal accessories (CS-G7) for endoscopes distributed to Japan. Sterilization instructions differ between Japanese product inserts and manufacturer documentation, potentially affecting proper device sterilization.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving inconsistent labeling of sterilization instructions. No injuries or illnesses are reported in the source material. The hazard is theoretical—potential for improper sterilization—rather than confirmed harm, fitting the rubric criterion for minor labeling errors and voluntary precautionary recalls.
Plain-English summary
Olympus Corporation of the Americas has recalled the Green Silicone Seal for Accessories (Model CS-G7), a reusable silicone seal used on endoscopes to seal the biopsy port and allow instruments to pass through while minimizing fluid leakage during endoscopic procedures. The recall affects 41 units.
The recall was initiated due to discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer's official Instructions For Use (IFU). These inconsistencies could result in users following incorrect sterilization procedures, potentially compromising the device's sterility before use.
The recalled devices were distributed internationally to Japan. The FDA has classified this as a Class II recall.
Healthcare facilities and endoscopy centers that have received these devices should identify the correct sterilization instructions and verify that all units are sterilized according to the manufacturer's official IFU before continued use. Contact Olympus Corporation of the Americas for clarification on the proper sterilization protocol.
The recalled product
- 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 mini
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- mis-labeling
- sterilization-discrepancy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Number: CS-G7. UDI-DI: 00821925038332
- 00821925001190. All lot numbers
Distribution
Distribution scope not specified by the agency.
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