China NMPA Product Recall - Ear thermometer

Guangzhou Beierkang Medical Device Co., Ltd. initiated a voluntary Level III recall of its ear thermometers (Guangdong Medical Device Registration Certificate 20152070005), as announced by the National Medical Products Administration on September 17, 2020. This action followed a product sampling by the Zhejiang Provincial Drug Administration, which identified a critical issue: the product instructions did not adhere to established regulatory requirements. The recall was conducted in accordance with the "Regulations on the Management of Medical Device Recalls" (Order No. 29 of the State Food and Drug Administration). While specific inspection dates for the sampling are not provided, the event prompted the company to take immediate corrective measures. A Level III recall signifies that the product's use is unlikely to cause adverse health consequences. The company's decision to voluntarily recall demonstrates its commitment to compliance and patient safety. Further details regarding the specific models, specifications, and batch numbers of the affected products are available in the accompanying Medical Device Recall Event Report Form. This recall underscores the importance of stringent adherence to product labeling and instruction standards within the medical device industry to ensure safe and effective use by consumers.