China NMPA Product Recall - Portable ultrasonic nebulizer

Shenzhen Raffles Nebulizer Medical Co., Ltd. has initiated a voluntary recall of a specific batch of its portable ultrasonic nebulizers, following a determination of non-compliance with established standards. The recall, indexed by the National Medical Products Administration (NMPA) as JGXX-2021-10742 and published on December 31, 2021, addresses product batch number 20180522004.The issue was identified during a random inspection, which revealed that the portable ultrasonic nebulizer, holding Registration Certificate No.: "粤食药监械（准）字2014第2231320号", did not meet required regulatory specifications. This proactive recall action by Shenzhen Raffles Nebulizer Medical Co., Ltd. is taken under the oversight of the NMPA and the Guangdong Provincial Drug Administration, demonstrating adherence to the country's medical device regulatory framework.As a result, the company is recalling all units from the affected production batch to ensure public safety and product quality. Further details regarding the models, specifications, and batch numbers involved are available in the "Medical Device Recall Event Report Form" attachment. This measure underscores the importance of continuous quality control and regulatory compliance within the medical device industry to protect consumer health.