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Face masks

FDA warns against using some N95 respirators, masks

April 12, 2023

Update 4/21/23: The FDA has provided additional guidance on using existing inventory of these masks here. For the latest news on COVID-19, visit http://bit.ly/AAPNewsCOVID19.

The Food and Drug Administration (FDA) has issued a warning regarding use of some surgical N95 respirators, surgical masks and pediatric face masks that may not protect people against contact with fluids as intended.

Two surgical N95 respirators by O&M Halyard should not be used:

  • Fluidshield surgical N95 respirator mask, orange (regular), level 3, model 46727 and
  • Fluidshield surgical N95 respirator mask, orange (small), level 3, model 46827.

The following masks manufactured by O&M Halyard should not be used when fluid barrier protection is needed, such as in surgical settings:

  • Halyard surgical mask, model 6000
  • Fluidshield level 3 fog-free surgical mask, wrap around visor, orange, model 28804
  • Fluidshield level 2 expanded chamber surgical mask with So Soft lining, blue and white, model 39123
  • high filtration surgical mask, silver, model 47625
  • The Lite One surgical mask, blue, model 48100
  • surgical mask, blue, model 48201
  • Halyard duckbill surgical mask, blue, model 48220
  • HYH surgical mask, teddy bears, model 48296
  • HYH surgical mask, model 48390
  • fog-free surgical mask, blue, model 49214
  • Halyard anti-fog surgical mask, green, model 49215
  • Halyard duckbill fog-free surgical mask, blue, model 49216
  • Halyard procedure mask, model 6001
  • Fluidshield level 1 procedure mask, lavender, model 25868
  • Fluidshield level 1 procedure mask, blue, model 25869
  • Fluidshield level 3 fog-free procedure mask, orange, model 28797
  • Halyard level 1 procedure mask, yellow, model 48388
  • procedure mask, tissue blue, model 47080
  • The Lite One procedure mask, blue, model 62356
  • HYH procedure mask, model 62363
  • child’s face mask, white with Disney characters, model 47127

The manufacturer has not initiated a recall of the masks but is conducting additional testing and working with the FDA. The FDA also is evaluating product samples and working with international regulatory authorities.

Anyone who has had a problem with an O&M Halyard respirator or mask should report it to the FDA’s MedWatch program. Health care personnel also should follow their facility’s reporting procedures. Questions can be directed to dice@fda.hhs.gov or 800-638-2041.

 

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