Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2140-2025·Announced 2025-07-30

Green endoscope silicone seals have conflicting sterilization instructions in Japan

Green Silicone Seals for Accessories, reusable 0-7 FR, model CS-G7, are being recalled because of discrepancies between the Japanese language package insert sterilization instructions and the manufacturer's IFU.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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

Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR, model number CS-G7, UDI-DI 00821925038332 and 00821925001190, 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 41 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: 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…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscope accessory
Hazard: instructions-discrepancy
sterilization-instructions
labeling
class-ii
Affected units: 41

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.

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.

See all 8 products in this recall →

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