Stop using these N95 masks, FDA says. There are ‘serious concerns’ with their quality

Katie Camero
·2 min read
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Federal health officials are warning health care professionals about “serious concerns” regarding the quality of certain N95 masks made by Shanghai Dasheng Health Products Manufacturing in China.

It’s unclear what is specifically wrong with the products — critical for protection against COVID-19 for medical workers — but the U.S. Food and Drug Administration and Centers for Disease Control and Prevention say the company “failed to control the design, labeling, and quality management” of the masks.

All approvals for N95s produced by Shanghai Dasheng have been revoked as of Aug. 13, meaning they are no longer authorized for emergency use and “may no longer be manufactured, assembled, sold or distributed” in the U.S.

N95 masks are those with a “very close facial fit and very efficient filtration of airborne particles,” the FDA says.

Although the warning was directed to health care professionals who work closely with COVID-19 patients, it doesn’t hurt to check if the box of N95 masks you purchased online or from stores made the cut.

Example of typical markings on approved N95 respirators.
Example of typical markings on approved N95 respirators.

Look for a seven-digit approval number that starts with the letters “TC-” at the bottom of your mask. If your mask is marked with any of the numbers listed below, then it is among those that have been revoked for quality concerns:

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 said it will keep health care professionals and the public updated as new information becomes available.

Experts say masks should be used alongside vaccination to slow and prevent further spread of the coronavirus, especially as more contagious variants make their rounds in the U.S.

More than 38.8 million coronavirus cases have been reported in the U.S., and more than 637,000 people have died from COVID-19 as of Aug. 30, according to Johns Hopkins University.