Z-0728-2025Class II

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

Name: Z-0728-2025 O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask
Creator: O&m Halyard, Inc.
Published: 2024-11-08
License: https://open.fda.gov/license/

O&M Halyard, Inc. / initiated 2024-11-08 / Open, Classified / root cause: manufacturing process

FDA source

O&M HALYARD, INC. began a recall of O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117 on 2024-11-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0728-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-08
Posted: 2024-12-20
Recalling firm: O&M Halyard, Inc.
Product: O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Product code: FXX Mask, Surgical
Reason for recall: 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 tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 211 cases
Distribution: Nationwide
Product codes and lots: UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0728-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0728-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20
Z-0729-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-01	2024-12-20

Product code FXX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)