China NMPA Product Recall - Skin suture

Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Level III recall for specific batches of its Skin Suture Devices. This action, reported on November 7, 2015, and published by the National Medical Products Administration (NMPA) on December 9, 2015, addressed a critical labeling error. Products manufactured between December 14, 2014, and May 24, 2015, were found to have a misprinted registration certificate number on their Chinese labels. The incorrect number displayed was “国食药监械（进）字2011 2662297” instead of the correct “国械注进20142665651”.

The recall affected 10 batches of PMW35 model skin suture devices, with approximately 14,321 units sold in China. While this mislabeling issue presented no direct risk to patient safety or product performance, the company proactively undertook the recall to mitigate potential regulatory compliance risks. The required actions included the immediate withdrawal of all unused affected products from the market. Furthermore, Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. informed relevant distributors and users about the corrective measures, instructing them to return any remaining affected inventory. This ensures adherence to NMPA regulatory standards.