FDA Recommends Stopping Use of Certain Owens and Minor Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks Because of Risk of Protection Failure

April 13, 2023
Editor's note: FDA issued an updated safety communication (https://voice.ons.org/news-and-views/fda-safety-communication-provides-recommendations-for-certain-om-halyard-surgical) regarding the recall on September 29, 2023.

On April 12, 2023, the U.S. Food and Drug Administration (FDA) issued a safety communication (https://www.fda.gov/medical-devices/safety-communications/risk-protection-failure-certain-om-halyard-surgical-n95-respirators-surgical-masks-and-pediatric)to healthcare providers, institutions, and consumers recommending that they do not use certain surgical N95 respirators manufactured by Owens and Minor Halyard and that they use certain surgical masks and pediatric face masks from Owens and Minor Halyard with caution. The recommendation comes after the masks failed fluid resistance performance tests. 

FDA Recommends Stopping Use of Certain Owens and Minor Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks Because of Risk of Protection Failure

FDA reported that laboratory test results show that certain models of Owens and Minor Halyard surgical N95 respirators, surgical masks, procedure masks, and pediatric face masks do not meet quality and performance expectations and may not provide fluid barrier protection. As of April 12, 2023, the manufacturer has not issued a voluntary recall, but it is conducting additional testing analysis. FDA said it is working with the manufacturer to evaluate those results.

Surgical N95 Respirators

The Owens and Minor Halyard surgical N95 respirators from the safety notice that should not be used include:

Device Name

Model Number

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

46727

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

46827

FDA recommended that healthcare providers, institutions, and consumers:

Surgical, Procedure, and Pediatric Face Masks

The Owens and Minor Halyard masks included in the safety notice that should not be used as fluid barrier protection are:

Manufacturer Device Name

Model Number

Surgical Masks

Halyard surgical mask

6000

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

28804

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

39123

High-filtration surgical mask, silver

47625

The Lite One surgical mask, blue

48100

Halyard classic surgical mask, blue, pleated with ties

48201

Halyard duckbill surgical mask, blue

48220

Halyard Health (HYH) surgical mask, teddy bears

48296

HYH surgical mask

48390

Fog-free surgical mask, blue

49214

Halyard anti-fog surgical mask, green

49215

Halyard duckbill, fog-free surgical mask, blue

49216

Procedure Masks

Halyard procedure mask

6001

Fluidshield level 1 procedure mask, lavender

25868

Fluidshield level 1 procedure mask, blue

25869

Fluidshield level 3 fog-free procedure mask, orange

28797

Halyard level 1 procedure mask, yellow

48388

Procedure mask, tissue blue

47080

The Lite One procedure mask, blue

62356

HYH procedure mask

62363

Pediatric Face Masks

Child face mask, white with Disney characters

47127

FDA recommended that healthcare providers, institutions, and consumers:

FDA said that it is committed to ensuring that Owens and Minor Halyard surgical N95 respirators and face masks are appropriate for their approved use and provide the approved level of protection. FDA is conducting ongoing evaluation for Owens and Minor Halyard respirators and mask samples and working with international regulatory authorities. Stay tuned for more updates if significant new information becomes available.

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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