# China NMPA Product Recall - Electronic thermometer

Source: https://www.globalkeysolutions.net/records/china_product_recall/aiola-medical-devices-shenzhen-co-ltd/ce5a1852-6809-48dc-a63f-4c3a0fbe1da7/
Source feed: China

> China NMPA product recall for Electronic thermometer by Aiola Medical Devices (Shenzhen) Co., Ltd. published January 11, 2022. Recall level: Level 3. Aiola Medical Devices (Shenzhen) Co., Ltd. has initiated a voluntary Level III recall of its electro

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Aiola Medical Devices (Shenzhen) Co., Ltd. voluntarily recalls electronic thermometers.
- Company Name: Aiola Medical Devices (Shenzhen) Co., Ltd.
- Publication Date: 2022-01-11
- Product Name: Electronic thermometer
- Recall Level: Level 3
- Recall Reason: The measuring instrument lacks type approval markings and serial numbers, lacks unique identifiers, and has issues with indication error and power supply compatibility.
- Discovering Company: Aiola Medical Devices (Shenzhen) Co., Ltd.
- Manufacturing Company: Aiola Medical Devices (Shenzhen) Co., Ltd.
- Summary: Aiola Medical Devices (Shenzhen) Co., Ltd. has initiated a voluntary Level III recall of its electronic thermometers, specifically batch number P20111765. This recall, published on January 11, 2022, by the National Medical Products Administration (NMPA) through the Guangdong Provincial Drug Administration, addresses several critical non-conformities identified with the medical devices. The primary issues leading to this recall include the absence of a required type approval mark and number for measuring instruments, a missing unique identifier, and documented problems related to indication error and power supply compatibility. These deficiencies indicate a failure to meet established quality and safety standards for medical devices. Under the guidance of the NMPA, the company is undertaking this recall to ensure patient safety and compliance with regulatory requirements. The voluntary nature of the recall signifies the company's commitment to addressing these product deficiencies promptly. Further details regarding product specifications and affected batch numbers are available in the accompanying Medical Device Recall Event Report Form. This action underscores the importance of stringent adherence to manufacturing and labeling standards within the medical device industry to protect public health.

Company: https://www.globalkeysolutions.net/companies/aiola-medical-devices-shenzhen-co-ltd/f134c014-367e-4651-86de-c6f89d225bb4/