FDA Medical Device Recalls (openFDA)
O&M HALYARD, INC.: O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
- Recall number
- Z-0729-2025
- Recalling firm
- O&M HALYARD, INC.
- Product
- O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
- Status
- Open, Classified
- Initiated
- 2024-11-08
- Posted
- 2024-12-20
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 637 cases
- Distribution
- Nationwide
- Lot, serial or model codes
- UDI-DI: 20680651475002 Lot Number: AM4119961 Exp. Date: 2029-04-28
- 510(k) numbers
- ["K823078","K831148"]
- PMA numbers
- not on file
- Product code
- FXX
- Firm FEI
- 3014527898
- Firm city
- Mechanicsville
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28