News September 08, 2023

Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication

The FDA is providing an update on O&M Halyard surgical N95 respirators and use of existing inventory.

On August 9, 2023, O&M Halyard sent a recall notice instructing customers not to use lot #AM2164811 of FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, (Model 46827), because this respirator may not provide adequate filtration protection to the user. This recall is a product removal of the one affected lot. Contact O&M Halyard if you have any questions about the recall or did not receive their notice at [email protected] using the Event # FA-2023-011 in the subject line.

For all other lots of FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, (Model 46827), the FDA recommendations are the same as the FDA recommendations provided on April 21, 2023, for the FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Regular), Level 3, (Model 46727), and are as follows:

If necessary, this model may continue to be used for respiratory protection when fluid barrier protection against splashes, sprays, or splatter is not needed, such as in non-surgical settings where exposure to liquid, bodily or other hazardous fluids is not expected.
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:
- Consider alternative options and seek an alternative surgical N95 respirator, if possible.
- In the absence of alternative options, the risk of fluid exposure can be mitigated by wearing a face shield over the respirator to prevent fluid penetration.

Unique Device Identifier (UDI) information provided by O&M Halyard:

FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, (Model 46827): 20680651468271
FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Regular), Level 3, (Model 46727): 20680651467274

The FDA continues to evaluate fluid resistance concerns identified through laboratory testing for both O&M Halyard surgical N95 respirators. This continues to be an evolving situation, and we will continue to keep the public informed about these surgical N95 respirators.

FDA recommendations provided on April 12, 2023, for certain O&M Halyard surgical masks (including procedure masks) and pediatric face masks have not changed. The FDA continues to work with the manufacturer to evaluate testing results and will continue to keep the public informed about the masks.

Date Issued: April 12, 2023

The U.S. 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.

The FDA is 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. Surgical masks referenced in this communication include masks that are labeled by the manufacturer as surgical or procedure masks. These types of masks are intended to provide fluid barrier protection. The FDA is continuing its evaluation.

Recommendations for Consumers, Health Care Providers, and Facilities Regarding Certain Surgical N95 Respirators by O&M Halyard

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

Manufacturer Device Name	Model Number
SURGICAL N95 RESPIRATORS
FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Regular), Level 3	46727
FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3	46827

Check your supply of surgical N95 respirators to determine if you have any of the affected models listed above.
Stop using these models.
Do not purchase models from the above list of surgical N95 respirators.
Stay alert for further updates and recommendations from the FDA or manufacturer.
Report any issues with the quality or performance of respirators or masks by O&M Halyard to the FDA. See “Reporting Problems with Your Device” below.

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

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:

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 SO SOFT Lining, Blue and White	39123
High Filtration Surgical Mask, Silver	47625
THE LITE ONE Surgical Mask, Blue	48100
Surgical Mask, Blue	48201
HALYARD Duckbill Surgical Mask, Blue	48220
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’s Face Mask, White with Disney®Characters	47127

Check your supply of surgical masks, procedure masks, and pediatric face masks to determine if you have any of the affected models listed above.
Do not use these models 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.
Do not purchase these models from the above list of surgical masks (including procedure masks) and pediatric face masks for use when fluid barrier protection against splashes, sprays, or splatter is needed.
Stay alert for further updates and recommendations from the FDA or manufacturer.
Report any issues with the quality or performance of masks or respirators by O&M Halyard to the FDA. See “Reporting Problems with Your Device” below.

Description of Concern with Using Certain O&M Halyard Surgical Respirators and Masks

Masks and respirators are examples of personal protective equipment that are used to protect the wearer from particles or liquid contaminating the face.

Certain O&M Halyard surgical respirators, surgical masks (including procedure masks), and pediatric face masks have failed fluid resistance performance tests at the expected protection level.

FDA Actions

As of April 12, 2023, O&M Halyard has not initiated a voluntary recall.

The manufacturer is conducting additional testing analysis. The FDA is working with the manufacturer to evaluate the additional testing results for the affected models.

The FDA is working 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 about this issue.

The FDA will keep the public informed if significant new information becomes available.

Reporting Problems with Your Device

If you are experiencing supply issues for surgical respirators, masks, or other devices, 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.

If you think you had a problem with surgical masks, pediatric face masks, or surgical N95 respirators manufactured by O&M Halyard, the FDA encourages you 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.

Questions?

If you have questions, email the Division of Industry and Consumer Education (DICE) at [email protected] or call 800-638-2041 or 301-796-7100.