Certain N95 Respirators Recalled by the FDA

Certain N95 Respirators Recalled by the FDA. Photo courtesy of John / stock.adobe.com.

The U.S. Food and Drug Administration (FDA) has announced that any N95 respirator manufactured by Shanghai Dasheng should no longer be used by healthcare professionals. They have been recalled due to the company not implementing, maintaining, or having a quality control system in place during manufacturing. This is according to the Centers for Disease Control (CDC) and the National Institute for Occupational Safety and Health (NIOSH).

Any prior emergency use authorizations for these respirators have since been revoked due to the loss of NIOSH-approval. To identify respirators that are no longer approved, keep an eye out for any of these numbers. Any brand name that uses these approval numbers is no longer approved:

TC-84A-4329, TC-84A-4330, TC-84A-4331, TC-84A-4332, TC-84A-4334, TC-84A-4335, TC-84A-4336, TC-84A-4337, TC-84A-4398, TC-84A-4399, TC-84A-4400, TC-84A-4401, TC-84A-4463, TC-84A-4464, TC-84A-4465, TC-84A-4466, TC-84A-4467, TC-84A-4468, TC-84A-4469,TC-84A-4470, TC-84A-4471, TC-84A-4472, TC-84A-4473, TC-84A-4483, TC-84A-4484, TC-84A-4485, TC-84A-4486, TC-84A-4487, TC-84A-8150, TC-84A-8425, TC-84A-8543, TC-84A-8544, TC-84A-8545, TC-84A-8546, TC-84A-8547, TC-84A-8634, TC-84A-8635, and TC-84A-8636.

The FDA recommends halting the use of these respirators as well as replacing them with any NIOSH-approved respirators. Any further problems can be reported to the FDA on its website.