China NMPA Product Recall - Medical molecular sieve oxygen generator

On October 15, 2019, Omron (Dalian) Co., Ltd. initiated a voluntary Class III recall of 63 units of its medical molecular sieve oxygen concentrators. The recall was reported to the National Medical Products Administration (NMPA) and the Liaoning Provincial Drug Administration. The primary issue prompting this action was that the noise levels of the affected oxygen concentrators did not conform to the technical specifications required for the product. Specific models involved in the recall include HAO-3000 (product number 20171000104UF), HAO-3201 (201801U), HAO-3010 (201806U), HAO-3200 (201806U), and HAO-3720 (201812U). These units were manufactured by Omron (Dalian) Co., Ltd. and hold registration certificates such as Liaoning Medical Device Registration Certificate 20152540035, 20152540036, and 20152540076. As a required action, the company is undertaking a voluntary recall to address the non-compliance with product noise level standards. This action is overseen by the regulatory framework established by the NMPA and local drug administrations, ensuring public safety and product quality standards are maintained.