More than 10 million N95 masks purchased using a $90 million contract are being recalled by the state of California, according to Brian Ferguson, spokesperson for the Governor’s Office of Emergency Services (Cal OES).
The state was notified on Sept. 11 that the National Institute for Occupational Safety and Health (NIOSH) had withdrawn its temporary certification of N95 masks made by the Santa Clara-based company Advoque Safeguard and immediately began recalling them, Ferguson told CNN.
According to Ferguson, 10.2 million of these masks have been received and 7.2 million of those had been distributed as of Sept. 8.
The California Department of Public Health (CDPH) notified all recipients of these masks of the change in certification and directed these masks “no longer be used in settings requiring the use of this essential PPE,” Ferguson said.
About the masks: N95 masks, which filters at least 95% of airborne particles, are the most common respirators approved by the Centers for Disease Control and Prevention (CDC). The CDC has recommended N95 masks for essential workers to reduce the risk of exposure to the coronavirus.
Ferguson explained that the NIOSH certification is an explicit requirement of all state contracts for N95 masks to ensure that frontline workers can be confident that the masks meet federal health and safety standards.
“It is a condition of the contract, and is incumbent upon the vendor, to maintain this certification,” he said.
Despite the state’s recall of all N95 masks made by Advoque Safeguard, the company announced in a letter to its customers and distributors on Wednesday that it is not conducting a recall of their masks, but have established a “product replacement program” as a courtesy to their customers.
“NIOSH has not asked us to implement a recall but has requested that we be diligent in informing our customers of the situation, and we are doing so,” Advoque Safeguard co-founder and chief technology officer Jason Azevedo said in a statement to CNN. “Additionally, Advoque Safeguard has instituted an exchange program for N95 respirators.”
The exact reason for the recall is unknown and has not been explained. CNN has reached out to the CDPH and NIOSH for additional details.