California recalls N95 masks obtained through $90M contract with Santa Clara-based company

California is recalling N95 masks obtained through a $90 million contract with Advoque, a company based in Santa Clara, after federal regulators revoked certification for the masks last week.

The California Department of Public Health announced Monday that organizations possessing Advoque N95 masks “immediately cease use and distribution of this product” and notify the state so officials can send replacements.

N95 masks are thought to be most effective in preventing spread of the coronavirus and have been in high demand during the COVID-19 pandemic.

The state’s N95 contracts require that the masks be federally certified, Office of Emergency Services spokesman Brian Ferguson said.

“It is a condition of the contract, and is incumbent upon the vendor, to maintain this certification,” Ferguson said in a statement. “The contract with this vendor has strong provisions to safeguard the state and the administration is exploring all available legal and contractual actions to protect the interests of Californians.”

In a letter to customers Wednesday, the company said the problem arose when some masks were tested at the National Institute for Occupational Safety and Health and fell short of the agency’s standards for N95 designation. Although California is recalling the masks, the company has not issued its own recall.

”The conditions around how the limited samples tested were stored or handled prior to the receipt by NIOSH of the samples are unknown,” the company’s chief business officer Paul Shrater wrote.

”To be clear, we have not been asked by NIOSH to conduct a recall and we are not conducting a recall,” he wrote. “Nevertheless we have established a product replacement program as a courtesy to our customers. This program will allow our customers to exchange their existing inventory for NIOSH-approved products.”

The company is working with the agency to get its masks re-certified so it can resume production at its Santa Clara plant. “That approval process is well underway, with the review process expected to be completed within 2 weeks,” Shrater wrote.

CEO Jason Azevedo wouldn’t comment on the matter.

NIOSH certification was also an issue with the Newsom’s highest profile mask deal: a nearly $1 billion contract California struck with BYD, a China-based automaker with a California-based subsidiary. The company failed to obtain federal certification for its N95 masks in time for two deadlines laid out in its contract before ultimately securing the certification in June.

This story was originally published September 18, 2020 at 5:00 AM.