Use of certain N95 masks should stop due to ‘serious’ quality concerns, FDA says

The U.S. Food and Drug Administration is alerting health care workers about certain N95 respirators, or masks, that are no longer approved for use due to "serious" quality concerns, according to an agency news release.

On Aug. 25, the FDA issued an alert to health care facility risk managers, procurement staff and health care personnel to stop using N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing Co., Ltd. 

"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," the FDA said. 

The following N95 respirators may still have an approval label from the NIOSH but are no longer authorized for emergency use by the FDA: 

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. 

d4e9f609-N95 mask production

FILE - A worker wears protective suit as precautionary measure make a N95 mask.

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The FDA suggests any Shanghai Dasheng masks bearing the numbers above should be replaced immediately with approved N95 respirator masks, which can be found on the NIOSH Certified Equipment list.

The recent FDA alert comes months after the Biden administration took the first step toward ending an emergency exception in April which allowed hospitals to ration and reuse N95 medical masks, the first line of defense between frontline workers and the deadly COVID-19 virus. 

The need to ration and reuse protective equipment during the onset of the pandemic was due to thousands of medical providers who died after being exposed and infected with COVID-19 while caring for patients without adequate protection. 

Critical shortages of masks, gowns, swabs and other medical supplies prompted the Trump administration to issue guidelines for providers to ration, clean, and reuse disposable equipment. Thus, throughout the pandemic, once a week many doctors and nurses were issued an N95 mask, which is normally designed to be tossed after each patient. 

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Now U.S. manufacturers say they have vast surpluses for sale, and hospitals say they have three to 12-month stockpiles. 

In response, the government says hospitals and healthcare providers should try to return to one mask per patient.

"The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies," said the agency in a letter to healthcare personnel and facilities in April. 

The letter was not an order: hospitals are still legally permitted to sterilize and reuse N95s. But in the coming weeks or months, the FDA will issue updated guidance and, eventually, require hospitals to revert to single-use, said Suzanne Schwartz, director of the FDA’s office of strategic partnerships and technology innovation. 

"The ability to decontaminate was purely a last resort, an extreme measure," Schwartz said. "From the FDA’s perspective, there is a need for us to move back towards contingency and conventional strategies, which is, you use the respirator for the interaction, and then you dispose of it and get a new one. We are in unison, in sync, with both NIOSH and OSHA in that position." 

FOX News contributed to this report.