China NMPA Product Recall - Arm-type electronic blood pressure monitor

Shenzhen Ailicon Medical Co., Ltd. has initiated a voluntary Class III recall for a specific batch of its arm-type electronic blood pressure monitors. The affected products, bearing batch number 20H085 and manufactured on September 1, 2020, were determined to be non-compliant with established quality and performance standards following a random inspection. This significant regulatory action is reported under the oversight of the National Medical Products Administration (NMPA), with the recall notification published on June 24, 2022, via the Guangdong Provincial Drug Administration Website. The recall targets medical devices (Registration Certificate No.: 粤械注准20182071146) to ensure public health and safety. Shenzhen Ailicon Medical Co., Ltd. is responsible for implementing this voluntary recall to rectify the identified non-conformance. Comprehensive details concerning the specific models, specifications, and affected batches are formally documented in an accompanying 'Medical Device Recall Event Report Form,' providing necessary information for stakeholders and users to comply with the recall process effectively.