The FDA warned healthcare professionals and the public to not use surgical N95 respirators manufactured by O&M Halyard and said to be cautious when using some of the company's surgical and pediatric face masks.
The agency said April 12 it is aware of lab test results showing certain respirators and masks "do not meet quality and performance expectations and may not provide expected fluid barrier protection to the wearer." An evaluation is underway.
Two respirators should not be used or bought, and 21 masks should not be worn in situations where "splashes, sprays or splatter" happens, such as surgical settings. The respirators are the regular orange fluidshield surgical N95 respirator mask, level 3, model number 46727; and the small orange fluidshield surgical N95 respirator mask, level 3, model number 46827.
As of April 13, O&M Halyard has not issued a recall. The FDA said it is working with the manufacturer as O&M Halyard conducts more tests.