China NMPA Product Recall - Natural latex rubber condoms

Guangzhou Licheng Trading Co., Ltd. initiated a voluntary Level III recall of specific natural latex condoms (batch N01180206) following a product quality failure. The issue was identified through an inspection report (YQ20181004) from the Hunan Provincial Medical Device Inspection and Testing Institute, which found that the affected batch failed to meet required standards for burst volume and pressure. This deficiency prompted the company to take action under the "Regulations on the Management of Medical Device Recalls." The recall involved 500,000 units, with 458,400 units sold within China. The company issued an emergency notice to suspend sales on August 27, 2018, and subsequently initiated a full recall by September 12, 2018. Distributors were instructed to return all remaining inventory and recall products from their customers within 15 days. While some products were retrieved, many had already been sold. Guangzhou Licheng Trading Co., Ltd. is cooperating with local drug regulatory authorities to manage the disposition of the recalled items. The recall report was submitted on September 29, 2018.