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.