China NMPA Product Recall - Natura-Drainable Pouch / Skin Barrier

The National Medical Products Administration (NMPA) released a report on August 29, 2025, detailing a voluntary recall initiated by ConvaTec Inc. ConvaTec (China) Medical Supplies Co., Ltd. reported this action, which concerns specific batches of the Natura-Drainable Pouch/Skin Barrier, an ostomy bag product registered under National Medical Device Registration No. 20210159. The primary reason for this Class III recall is the discovery of manufacturing defects, specifically holes found in the bottom of the affected products. These holes could lead to product leakage, posing a potential risk to users. ConvaTec Inc., the manufacturer, has proactively taken steps to address this quality concern through a voluntary recall. It is important to note that the specific products implicated in this recall were not imported into the Chinese market. The NMPA's involvement highlights the robust regulatory oversight within the medical device sector to ensure product safety and quality. Further details regarding the affected models, specifications, and batch numbers are available in the official "Recall Event Report Form" provided by ConvaTec (China) Medical Supplies Co., Ltd.