# China NMPA Product Recall - Foot bath therapy massager

Source: https://www.globalkeysolutions.net/records/china_product_recall/shandong-longma-health-products-co-ltd/21b61335-7796-4a9e-8490-3be13366ebc5/
Source feed: China

> China NMPA product recall for Foot bath therapy massager by Shandong Longma Health Products Co., Ltd. published November 28, 2017. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) reported on November 28, 2017, a Class III volun

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shandong Longma Health Products Co., Ltd. voluntarily recalls foot bath massagers.
- Company Name: Shandong Longma Health Products Co., Ltd.
- Publication Date: 2017-11-28
- Product Name: Foot bath therapy massager
- Recall Level: Level 3 Recall
- Recall Reason: The discovery of substandard leakage current values in patients during random inspections may pose a risk.
- Discovering Company: Shandong Longma Health Products Co., Ltd.
- Manufacturing Company: Shandong Longma Health Products Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) reported on November 28, 2017, a Class III voluntary recall initiated by Shandong Longma Health Products Co., Ltd. The recall pertains to their Foot Bath Therapy Massager (Registration No.: (准)字2013第2260308号). This decisive action was prompted by findings from routine random inspections, which revealed that the product exhibited unqualified leakage current values. Such deviations from safety standards are critical as they can pose a significant electrical hazard to users, potentially leading to electric shock or other safety incidents during operation. Shandong Longma Health Products Co., Ltd. proactively reported this safety concern and commenced the voluntary recall process, demonstrating an adherence to product safety responsibilities. A Class III recall typically indicates a situation where exposure to a violative product is not likely to cause adverse health consequences. However, the potential for unqualified leakage current necessitated immediate removal from the market to mitigate any potential risk, no matter how small. This regulatory event underscores the NMPA's framework for overseeing product quality and safety within the medical device sector, relying on company-initiated actions following inspection findings to safeguard public health and ensure compliance with established safety benchmarks for therapeutic and health-related devices. The company's immediate action aims to prevent consumer exposure to the identified defect.

Company: https://www.globalkeysolutions.net/companies/shandong-longma-health-products-co-ltd/39cd8448-4eaa-4fd1-9dad-d866376d791b/