法國保險套召回事件消息更新
針對法國監管機構近期宣布召回部分保險套產品，其中包括岡本產品，我們想向消費者提供以下說明。
此次召回僅限於透過特定通路銷售的特定產品。
岡本在全球多個國家與地區銷售的產品均已通過必要的註冊與核准，符合各自市場適用的品質標準與法律要求。被召回的兩款產品僅登記在日本地區，但這些產品乃透過非官方管道進入法國市場，而非官方授權的管道。由於這些產品未獲得歐洲所需的CE標誌，法國監管機構認定其不符合歐盟醫療器材規範（EU 2017/745）。我們所有透過授權管道供應法國的岡本產品，均已正式獲准在當地市場銷售，為CE標記的IIb類醫療器材。上述召回產品僅限於透過非官方管道進入法國市場的特定批次，因此與透過官方授權管道銷售的岡本產品毫無關聯。
所有透過授權管道銷售的岡本產品均符合相關法律、法規及標準。
所有全球銷售的岡本保險套產品均已取得相關註冊證書（如適用），並符合相關標示要求。官方產品的包裝符合當地相關法律法規，通常包含授權代理人資訊及註冊證書號碼（如適用）。我們始終致力於履行對全球消費者的責任。所有岡本產品均通過嚴格的品質檢查與合規審查。
關於法國的召回事件，我們將持續跟進持續的情勢，並採取適當措施。我們始終致力於提供安全可靠的產品。非常感謝您的理解與支持。
岡本株式會社
2026.08.31
Statement on the Recall of Okamoto Products in the French Market
Regarding the recent announcement by the French regulatory authorities concerning the recall of certain condom products, which included Okamoto products, we would like to provide the following explanation to consumers.
1. The recall is limited to specific products sold through specific channels.
The products sold by Okamoto in various countries and regions worldwide have each undergone the necessary registrations and approvals and comply with the quality standards and legal requirements applicable in their respective markets. The two models of the products subject to the recall are designed for Japan market only, which nevertheless entered the French market through unofficial channels outside of our authorized channels.
As these products did not bear the CE mark required in Europe, the French regulatory authorities determined that they did not comply with the EU Medical Device Regulation (EU) 2017/745. All Okamoto products that we supply to France through authorized channels have been formally approved for sale in the local market as CE marked Class IIb medical devices. The recalled products mentioned above are limited to specific lots that entered the French market through unofficial channels and therefore have no connection whatsoever with Okamoto products sold through authorized channels.
2. All Okamoto products sold through authorized channels comply with applicable
laws, regulations, and standards.
All Okamoto condom products sold globally have obtained relevant registration certificates, where applicable, and comply with the applicable requirements concerning labeling.
The packaging of official products complies with applicable local laws and regulations and typically includes the authorized agent information and the registration certificate number, where applicable. We have always been committed to fulfilling our responsibilities to the consumers worldwide. All Okamoto products undergo strict quality inspections and compliance reviews.
Regarding the recall incident in France, we will continue to follow-up on the ongoing situation and take the necessary measures as appropriate. We remain committed to delivering safe and reliable products. Your understanding and support is highly appreciated.
Okamoto Industries, Inc.
31 August 2026
