Update: Recommendations for Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
September 29, 2023
The FDA is providing an update to consumers, health care providers, and facilities about certain surgical N95 respirators and masks manufactured by O&M Halyard. This update includes the current recommendations for these products based on new data and information provided by O&M Halyard. The FDA will continue to work with O&M Halyard to ensure its surgical N95 respirators, surgical masks, and pediatric face masks are in compliance with regulatory requirements.
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 can be used according to the product labeling for respiratory and fluid barrier protection to the wearer (exclusion noted below):
Surgical N95 Respirators
| Manufacturer 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 |
- Be aware that on August 9, 2023, O&M Halyard initiated a voluntary recall of FLUIDSHIELD Surgical N95 Respirator Mask, Orange (Small), Level 3, Model 46827, Lot Number AM2164811 because this lot failed particulate filtration testing and should not be used. This recall is a product removal of the affected lot in distribution.
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
Surgical masks referenced in this communication include masks that are labeled by the manufacturer as surgical or procedure masks. These types of masks are expected to provide fluid barrier protection.
The following surgical masks and procedure masks by O&M Halyard can be used according to the product labeling for fluid barrier protection:
Surgical Masks
| Manufacturer Device Name | Model Number | Device Identifier (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
| Manufacturer Device Name | Model Number | Device Identifier (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 surgical masks and procedure masks by O&M Halyard will not provide fluid barrier protection to the wearer, 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
| Manufacturer Device Name | Model Number | Device Identifier (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
| Manufacturer Device Name | Model Number | Device Identifier (DI) Number |
|---|---|---|
| Procedure Mask, Tissue Blue | 47080 | 20680651470809 |
| THE LITE ONE Procedure Mask, Blue | 62356 | 20680651623564 |
| HYH Procedure Mask | 62363 | 20680651623632 |
The manufacturer has confirmed to the FDA that the following O&M Halyard surgical masks, procedure masks, and pediatric face masks are not marketed in the United States or have been discontinued. If you have any of the following products in your supply, these masks 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
| Manufacturer Device Name | Model Number | Device Identifier (DI) Number |
|---|---|---|
| Halyard Surgical Mask | 6000 | N/A |
| High Filtration Surgical Mask, Silver | 47625 | 20680651476252 |
| Surgical Mask, Blue | 48201 | 20680651482017 |
Procedure Masks
| Manufacturer Device Name | Model Number | Device Identifier (DI) Number |
|---|---|---|
| Halyard Procedure Mask | 6001 | N/A |
Pediatric Face Masks
| Manufacturer Device Name | Model Number | Device Identifier (DI) Number |
|---|---|---|
| Child’s Face Mask, White with Disney® Characters | 47127 | 20680651471271 |
Device Description
Masks and respirators are examples of personal protective equipment that are used to protect the wearer from particles or liquid contaminating the face.
FDA Actions
The FDA will continue to work with O&M Halyard to conduct postmarket surveillance of these products, monitor manufacturing activities and quality management processes, and ensure these products are in compliance with regulatory requirements.
The FDA will keep the public informed as any significant new information becomes available.
A timeline and summary of the FDA’s previous communications related to these devices is provided below.
| Date | Event |
|---|---|
| 4/12/2023 | The FDA issued a safety communication: Risk of Protection Failure with Certain O&M Halyard Surgical N95 respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication. (Updated 4/21/23 and 9/8/23) |
Unique Device Identifier (UDI)
The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. For more information on UDI, please visit Unique Device Identification System (UDI Systems).
Reporting Problems with Your Device
If you are experiencing supply issues for surgical respirators, masks, or other devices, you may 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 DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.