FDA Alerts Health Care Providers to Stop Using Certain N95 Respirators


The Food and Drug Administration (FDA) released a letter ​yesterday alerting health care providers to stop using certain N95 respirators manufactured by one specific company, Shanghai Dasheng Health Products Manufacturing Co., Ltd. (Shanghai Dasheng). Providers currently using N95 respirators manufactured by Shanghai Dasheng should cease utilizing them. 

The Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) revoked all respirator approvals previously issued to Shanghai Dasheng because the company did not implement, maintain, and control a quality management system. All previously authorized Shanghai Dasheng respirators are no longer authorized for emergency use as a result of the loss of NIOSH-approval.   

More information can be found in the FDA letter here​.