The US Food and Drug Administration (FDA) is recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators manufactured by O&M Halyard and to use caution with certain surgical masks and pediatric face masks manufactured by O&M Halyard.

According to a safety communication on its website, the FDA has been made aware of laboratory test results that show certain models of O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks do not meet quality and performance expectations and may not provide expected fluid barrier protection to the wearer.

As of April 12, O&M Halyard has not initiated a voluntary recall. The manufacturer is conducting additional testing analysis, according to the FDA. 

The surgical masks referenced include masks that are labeled by the manufacturer as surgical or procedure masks. These types of masks are intended to provide fluid barrier protection. 

Surgical N95 Respirators by O&M Halyard

The FDA says the following surgical N95 respirators by O&M Halyard should not be used:

  • FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Regular), Level 3, model 46727
  • FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, model 46827

Surgical Masks, Procedure Masks, or Pediatric Face Masks by O&M Halyard

According to the FDA, the following surgical masks and pediatric face masks by O&M Halyard should not be used when fluid barrier protection against splashes, sprays, or splatter is needed, such as in surgical settings where exposure to liquid, bodily, or other hazardous fluids may occur:

Surgical masks

  • 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

Procedure masks

  • 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

Pediatric face masks 

  • Child’s Face Mask, White with Disney Characters, model 47127

The FDA is working with the manufacturer to evaluate the additional testing results for the affected models and to ensure O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks are appropriate for their intended use and provide the level of protection claimed. 

The FDA continues to evaluate product samples and assess for possible concerns for O&M Halyard respirators and masks. The FDA is also working with international regulatory authorities on this issue. 

Those experiencing supply issues for surgical respirators, masks, or other devices, can contact the FDA about a medical device supply chain issue. Reporting supply issues informs the FDA of how it may be able to help address device supply availability.

The FDA encourages those who believe they had a problem with surgical masks, pediatric face masks, or surgical N95 respirators manufactured by O&M Halyard to report the problem through the MedWatch Voluntary Reporting Form.

Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.