# China NMPA Product Recall - Endoscope cleaning and sterilization machine (product name: ENDOCLENS-NSX)

Source: https://www.globalkeysolutions.net/records/china_product_recall/advanced-sterilization/e3271473-e962-4318-9f5c-4494206bf225/
Source feed: China

> China NMPA product recall for Endoscope cleaning and sterilization machine (product name: ENDOCLENS-NSX) by Advanced Sterilization published December 22, 2014. Recall level: Level II. Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for its

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. is voluntarily recalling its endoscope cleaning and sterilization machine (product name: ENDOCLENS-NSX).
- Company Name: Advanced Sterilization
- Publication Date: 2014-12-22
- Product Name: Endoscope cleaning and sterilization machine (product name: ENDOCLENS-NSX)
- Recall Level: Level II
- Recall Reason: The endoscope cleaning and sterilizing machine (product name: ENDOCLENS-NSX) may experience some software malfunctions after a power outage lasting more than 24 hours.
- Discovering Company: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Advanced Sterilization
- Summary: Johnson & Johnson (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for its ENDOCLENS-NSX Endoscope Cleaning and Sterilization Machine, as reported by the National Medical Products Administration (NMPA) on December 22, 2014. The recall was prompted by the potential for software malfunctions to occur in the device following a power outage lasting more than 24 hours. The affected product is designed for automatic cleaning and high-level disinfection of immersion-compatible flexible endoscopes. This recall impacts all serial numbers of the ENDOCLENS-NSX machine. Globally, approximately 27,000 units were affected, with 342 units imported into China. Specifically, 197 units were sold in China, 120 units were held as fixed assets, and 25 units remained in inventory. The company, through its responsible unit Advanced Sterilization Products, is undertaking this corrective action under the oversight of regulatory bodies including the NMPA and the Shanghai Municipal Food and Drug Administration, reflecting adherence to medical device regulatory frameworks.

Company: https://www.globalkeysolutions.net/companies/advanced-sterilization/867b38a5-f105-47d6-a56a-86b283489473/