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

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.

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:

• Check their supply of surgical N95 respirators for any of the affected models.
• Stop using the affected models.
• Do not purchase models from the listed surgical N95 respirators.
• Stay alert for updates and recommendations from FDA or the manufacturer.
• Report any issues (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) with the quality or performance of Owens and Minor Halyard respirators or masks to FDA.

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:

• Check their supplies of surgical, procedure, and pediatric face masks for any of the affected models.
• Stop using the affected masks as fluid barrier protection against splashes, sprays, or splatters.
• Do not make new purchases of the affected models of surgical, procedure, and pediatric face masks.
• Stay alert for updates and recommendations from FDA or the manufacturer.
• Report any issues (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) with the quality or performance of Owens and Minor Halyard masks or respirators to FDA.

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.