China NMPA Product Recall - Reservoirs

The National Medical Products Administration (NMPA) has announced a Class II voluntary recall initiated by Smiths Medical ASD, Inc. This recall pertains to certain reservoir products, reported by Smiths Medical Devices (Shanghai) Co., Ltd. The primary issue identified is a potential weakening of the weld seam surrounding the medicine bag within the product's plastic casing. This structural compromise could lead to leakage of medication from the periphery of the medicine bag, posing a potential risk. The affected reservoirs hold National Medical Device Registration Certificate 20193141729. Smiths Medical ASD, Inc., the manufacturer, proactively initiated this recall to address the quality concern. It is important to note that, according to the recall announcement dated August 7, 2025, the specific products implicated in this recall were not imported into the Chinese market. The "Medical Device Recall Event Report Form" contains further details regarding the affected models and additional information. This action underscores the manufacturer's commitment to product safety and compliance with NMPA's regulatory framework, even for products not directly distributed within China.