FDA Safety Communication Provides Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks

October 02, 2023

On September 29, 2023, the U.S. Food and Drug Administration (FDA) issued an updated safety communication to consumers, healthcare providers, and facilities about certain surgical N95 respirators and masks manufactured by Owens and Minor (O&M) Halyard. FDA updated its recommendations for the products based on new data and information from O&M Halyard. 

FDA

Recommendations for Consumers, Healthcare Providers, and Facilities for Certain O&M Halyard Surgical N95 Respirators  

FDA said that wearers can use the following O&M Halyard surgical N95 respirators according to the product labeling for personal respiratory and fluid barrier protection, with one exclusion indicated beneath the table: 

Surgical N95 Respirators 

Device Name 

Model Number 

Device Identifier (DI) Number 

Fluidshield surgical N95 respirator mask, orange (regular), level 3 

46727 

20680651467274 

Fluidshield surgical N95 respirator mask, orange (small), level 3 

46827 

20680651468271 

Exclusion: On August 9, 2023, O&M Halyard initiated a voluntary recall (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=202959) of Fluidshield surgical N95 respirator mask, orange (small), level 3, model 46827, lot number AM2164811, because it failed particulate filtration testing and should not be used. That recall is a product removal of the affected lot in distribution.  

Recommendations for Consumers, Healthcare Providers, and Facilities Regarding Certain O&M Halyard Masks Labeled as Surgical, Procedure, or Pediatric Face Masks  

FDA said that individuals may use the following O&M Halyard surgical masks and procedure masks according to the product labeling for fluid barrier protection:  

Surgical Masks 

Device Name 

Model Number 

DI Number 

Fluidshield level 2 expanded chamber surgical mask with So Soft lining, blue and white 

39123 

20680651391234 

Fluidshield level 3 fog-free surgical mask, wrap around visor, orange 

28804 

20680651288046 

Procedure Masks 

Device Name 

Model Number 

DI Number 

Halyard level 1 procedure mask, yellow 

48388 

20680651483885 

Fluidshield level 1 procedure mask, lavender 

25868 

20680651258681 

Fluidshield level 1 procedure mask, blue 

25869 

20680651258698 

Fluidshield level 3 fog-free procedure mask, orange 

28797 

20680651287971 

The following O&M Halyard surgical and procedure masks will not provide the wearer with fluid barrier protection and should continue to 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 

Device Name 

Model Number 

DI Number 

The Lite One surgical mask, blue 

48100 

20680651481003 

Halyard duckbill surgical mask, blue 

48220 

20680651482208 

Halyard anti-fog surgical mask, green 

49215 

20680651492153 

Fog-free surgical mask, blue 

49214 

20680651492146 

Halyard duckbill fog-free surgical mask, blue 

49216 

20680651492160 

HYH surgical mask, teddy bears 

48296 

20680651482963 

HYH surgical mask 

48390 

20680651483908 

Procedure Masks 

Device Name 

Model Number 

DI Number 

Procedure mask, tissue blue 

47080 

20680651470809 

The Lite One procedure mask, blue 

62356 

20680651623564 

HYH procedure mask 

62363 

20680651623632 

FDA said that the manufacturer confirmed that the following O&M Halyard surgical, procedure, and pediatric face masks are not marketed in the United States or have been discontinued. Any of the following products in supply should continue to 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 

Device Name 

Model Number 

DI Number 

Halyard surgical mask 

6000 

N/A 

High filtration surgical mask, silver 

47625 

20680651476252 

Surgical mask, blue 

48201 

20680651482017 

Procedure Mask 

Device Name 

Model Number 

DI Number 

Halyard procedure mask 

6001 

N/A 

Pediatric Face Masks 

Device Name 

Model Number 

DI Number 

Child’s face mask, white with Disney® characters 

47127 

20680651471271 

FDA said it would work with O&M Halyard to conduct postmarket surveillance, monitor manufacturing activities and quality management processes, and ensure the products comply with regulatory requirements and that it would inform the public with any significant new information. Read FDA’s previous communications (https://www.fda.gov/medical-devices/safety-communications/update-recommendations-certain-om-halyard-surgical-n95-respirators-surgical-masks-and-pediatric-face?utm_medium=email&utm_source=govdelivery#651a530bd761e) about the recall. 

For supply issues with surgical respirators, masks, or other devices, contact FDA to report a medical device supply chain issue (https://www.fda.gov/medical-devices/medical-device-supply-chain-and-shortages/notify-fda-about-medical-device-supply-issue). Reporting supply issues may help address device supply availability. 

Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program. 


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