O&M HALYARD, INC. recalls O&M Halyard Procedure Mask with SO SOFT* Earloops

Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.

O&M Halyard issued Urgent: Product Field Action via email on 11/8/24 to Distributors and End-Users. Letter states reason for recall, health risk and action to take: Customers (end-users): 1. REVIEW your inventory for the affected product code and specific lot number. 2. DESTROY or DISCARD the product per the facility s standard disposal procedure for face masks. 3. COMMUNICATE this Field Action to staff to ensure awareness of it. 4. RETURN the completed Field Action Response Form to OMRA_RECALLS@owens-minor.com as soon as possible even if you have no current product inventory. 5. Any adverse events associated with the use of the affected product should be reported to complaints@owens-minor.com. 6. If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. Distributors: 1. REVIEW your inventory for the affected product code and specific lot number. 2. DESTROY or DISCARD the product per the facility s standard disposal procedure for face masks. 3. COMMUNICATE this voluntary Field Action to staff to ensure awareness of it. 4. If any of the affected lot identified above was further distributed, please ensure all end-users are appropriately notified of this Field Action and maintain records of effectiveness. 5. Any adverse events associated with the use of the affected product should be reported to complaints@owens-minor.com. 6. RETURN the completed Field Action Response Form to OMRA_RECALLS@owens-minor.com as soon as possible even if you have no current product inventory. If you have any questions, please email OMRA_RECALLS@owens-minor.com using the Event # FA-2024-034 in the header of the response.

• FDA enforcement recordOfficial FDA database entry for Z-0728-2025
• FDA 510(k) clearance · K823078The device's official FDA premarket clearance record
• FDA 510(k) clearance · K831148The device's official FDA premarket clearance record
• FDA device classification · FXXOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4040The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find O&M HALYARD, INC.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.