China NMPA Product Recall - Disposable medical masks

Guangdong Bio-Con Medical Technology Co., Ltd., now operating as Guangdong Mingli Medical Technology Co., Ltd., has initiated a voluntary recall of specific batches of its disposable medical masks. This action, announced by the National Medical Products Administration (NMPA) on August 26, 2022, addresses products from production batch numbers 20210104 and 20220104.

The recall stems from identified product deficiencies that pose potential concerns regarding mask efficacy and user safety. Specifically, the masks were found to have insufficient tensile strength, measuring below 10N at the connection points, which could compromise their integrity during use. Additionally, some masks exhibited ventilation resistance greater than 49Pa/cm

², which falls outside acceptable parameters and could affect breathability. These findings indicate a clear non-conformance with the stringent technical requirements stipulated in the Guangdong Medical Device Registration Standard 20202141141 for "Disposable Medical Masks." As a result, the company is undertaking a voluntary recall, a required action under the regulatory framework to ensure all medical devices meet established quality and safety benchmarks.