# China NMPA Product Recall - Acumen IQ Finger Cuff Sensor

Source: https://www.globalkeysolutions.net/records/china_product_recall/edwards-lifesciences-llc/93b5b561-735a-405a-99c9-b03721b6ab4f/
Source feed: China

> China NMPA product recall for Acumen IQ Finger Cuff Sensor by Edwards Lifesciences LLC published January 05, 2026. Recall level: Level 3 Recall. Edwards Lifesciences LLC has initiated a voluntary Level III recall for its Acumen IQ Finger Cuff Fi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Edwards Lifesciences LLC is voluntarily recalling its Acumen IQ Finger Cuff sensor.
- Company Name: Edwards Lifesciences LLC
- Publication Date: 2026-01-05
- Product Name: Acumen IQ Finger Cuff Sensor
- Recall Level: Level 3 Recall
- Recall Reason: Production process control defects
- Discovering Company: Edwards (Shanghai) Medical Supplies Co., Ltd.
- Manufacturing Company: Edwards Lifesciences LLC
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/edwards-lifesciences-llc/d78876e8-6a4a-49b4-8cb5-30579a7ed097/