China NMPA Product Recall - Acumen IQ Finger Cuff Sensor

Edwards Lifesciences LLC has initiated a voluntary Level III recall for its Acumen IQ Finger Cuff Finger Sensor. This action, reported by Edwards (Shanghai) Medical Supplies Co., Ltd. and announced by the National Medical Products Administration (NMPA) on January 5, 2026, stems from identified defects in the product's production process control. The affected medical device holds National Medical Device Registration Certificate No. 20242070591 within the Chinese regulatory framework. The recall specifically targets particular product models, specifications, and batches, with detailed information available in an attached Medical Device Recall Event Report Form. While Becton, Dickinson and Company acquired Edwards' relevant business on September 3, 2024, the product registration certificates had not yet been formally transferred at the time of this recall. The primary required action is the prompt and systematic removal of the defective Acumen IQ Finger Cuff Finger Sensors from the market to ensure patient safety and compliance with NMPA's medical device regulations. This measure highlights the manufacturer's responsibility to address product quality concerns and uphold manufacturing standards.