Reusable Endoscope Seals Recalled Due to Sterilization Instructions Discrepancy
Olympus reusable silicone seals for endoscopes are recalled because Japanese-language package instructions differ from the official sterilization guidance. Users following the incorrect instructions may not properly sterilize the device.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product where injury has not yet been reported. Discrepancies in sterilization instructions for reusable medical devices could lead to inadequate sterilization and potential cross-contamination if users follow the incorrect guidance.
Plain-English summary
Olympus Corporation of the Americas is recalling Blue Silicone, Reusable Silicone Seals (Model CS-B612), used to seal the biopsy port of endoscopes. These reusable seals are used during endoscopic procedures to seal off the working channel and allow instruments to be passed through while minimizing fluid leakage. The recall affects 19 units distributed to Japan.
The recall was issued due to discrepancies between sterilization instructions in the Japanese-language product package insert and the manufacturer's official Instructions for Use (IFU). Users following the incorrect Japanese-language instructions may not properly sterilize the device, which could compromise patient safety.
Healthcare facilities in Japan that have received this product should verify they are following the sterilization instructions in the manufacturer's official IFU rather than the Japanese-language package insert. For correct sterilization guidance, users should contact Olympus Corporation of the Americas directly.
The recalled product
- 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 fl
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- instruction-discrepancy
- sterilization-error
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-B612. UDI-DI: 00821925038318
- 00821925001176. All lot numbers
Distribution
Distribution scope not specified by the agency.
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