China NMPA Product Recall - Natural latex rubber condoms

On May 24, 2022, Maoming Jiangyuan Latex Products Co., Ltd. initiated a voluntary Class III recall of its natural latex condoms, specifically targeting production batch number 71005A1. This action was prompted by critical quality defects and potential safety hazards identified within the product line. Investigations revealed that certain products from the affected batch failed to meet established standard requirements for pinhole performance. Such defects are significant as they can compromise the intended barrier function of the product, posing a safety risk to consumers. The recall is being conducted under the oversight of China's National Medical Products Administration (NMPA), with direct involvement from the Guangdong Provincial Drug Administration, ensuring compliance with medical device regulations. The required action for Maoming Jiangyuan Latex Products Co., Ltd. is to effectively execute this voluntary recall, remove the non-conforming products from the market, and address the underlying quality control issues. Further detailed information pertaining to the specific recall numbers, product specifications, and batch details is formally documented in the "Medical Device Recall Event Report Form" issued by the company.