Reusable endoscope silicone seals have conflicting sterilization instructions in Japan
Blue Silicone Reusable Silicone Seals 6-12 FR, model CS-B612, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.
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: FDA Class II recall for a documentation discrepancy between two sets of instructions, with no device defect or clinical consequence stated.
Plain-English summary
Blue Silicone, Reusable Silicone Seal 6 - 12 FR, model number CS-B612, UDI-DI 00821925038318 and 00821925001176, is being recalled across all lot numbers. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel, and some contain a lumen allowing instruments to be passed. The action covers 19 units.
The stated reason is discrepancies between the sterilization instructions in the Japanese language product package inserts and those published in the manufacturer's product Instructions For Use. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Distribution was international, to Japan.
Facilities should identify affected stock using the model number and UDI-DI codes above and follow the instructions issued by the manufacturer.
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
- Affected units
- 19
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.
Part of a larger recall action
This product is one of 8 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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