China NMPA Product Recall - Electronic thermometer

Aiola Medical Devices (Shenzhen) Co., Ltd. initiated a voluntary recall of its electronic thermometers, as announced by the National Medical Products Administration (NMPA) on January 27, 2021. The recall was prompted by the company's discovery that the automatic shutdown function of these devices exceeded its specified operational range. Instead of shutting down within the stipulated 8±1 minutes, the thermometers remained active for an additional approximately 20 seconds. This issue posed a potential deviation from the product's intended specifications. Operating under the oversight of the NMPA and the Guangdong Provincial Drug Administration, Aiola Medical Devices (Shenzhen) Co., Ltd. classified this as a Class III recall, indicating a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences. The company voluntarily undertook this corrective action to address the identified non-conformance. Specific models, specifications, and batch numbers of the affected electronic thermometers are detailed in the associated Medical Device Recall Event Report Form, which advises stakeholders on the scope of the recall. This action underscores the company's commitment to product safety and regulatory compliance.