O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable… recallZ-0729-2025 · O&M Halyard, Inc. · initiated Nov 8, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from O&M Halyard, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected] 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 [email protected]. 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 [email protected]. 6. RETURN the completed Field Action Response Form to [email protected] as soon as possible even if you have no current product inventory. If you have any questions, please email [email protected] using the Event # FA-2024-034 in the header of the response.
Recall details
- Recall number
- Z-0729-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 8, 2024
- Posted by the FDA
- Dec 20, 2024
- Recalling firm
- O&M Halyard, Inc.
- Quantity
- 637 cases
- Product code
- FXX
- FDA submissions
- K823078, K831148
- Distribution
- Nationwide
Product description
O&M Halyard SOFT TOUCH II Surgical Mask, Blue-Disposable surgical mask Product Code: 47500
Code information (models, lots, serial numbers)
UDI-DI: 20680651475002 Lot Number: AM4119961 Exp. Date: 2029-04-28
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Halyard 47500O&M Halyard, Inc. · Mask, surgical1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 95804).
- Z-0728-2025 · Open, ClassifiedO&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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