China NMPA Product Recall - Natural latex rubber condoms

Guangzhou Shuangyi Latex Products Co., Ltd. has initiated a voluntary Level III recall for specific batches of its Natural Latex Condoms. The recall, publicly announced on January 7, 2019, followed sampling inspections commissioned by the National Medical Products Administration (NMPA) and conducted by the Hubei Provincial Medical Device Quality Supervision and Inspection Institute. These inspections, detailed in report 2018GJW118, revealed that the condoms (batch SY0031704, model 52mm Smooth Surface, totaling 144,000 pieces) did not meet standard requirements for "burst volume and pressure." This non-compliance affects the product's ability to provide protection against pregnancy and sexually transmitted diseases. In response to these findings, the company promptly issued an urgent notification on August 25th to distributors to cease sales of the identified batch. All 581 boxes of unsold products were subsequently recalled from the market. Guangzhou Shuangyi Latex Products Co., Ltd. has committed to cooperating with regulatory authorities to ensure proper handling and disposal of the recalled items, demonstrating adherence to NMPA's medical device oversight.