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O&M Halyard Procedure Mask with SO SOFT* Earloops… recallZ-0728-2025 · O&M Halyard, Inc. · initiated Nov 8, 2024

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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-0728-2025
Status
Open, Classified
Initiated by the company
Nov 8, 2024
Posted by the FDA
Dec 20, 2024
Recalling firm
O&M Halyard, Inc.
Quantity
211 cases
Product code
FXX
FDA submissions
K823078, K831148
Distribution
Nationwide

Product description

O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117

Code information (models, lots, serial numbers)

UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K823078, K831148 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 95804).

Sources and updates

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