O&M HALYARD, INC.: Device Recall

Recall #Z-0728-2025 · 11/08/2024

Class II: Risk

Recall Details

Recall Number: Z-0728-2025
Classification: Class II
Product Type: Device
Recalling Firm: O&M HALYARD, INC.
Status: Ongoing
Date Initiated: 11/08/2024
Location: Mechanicsville, VA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 211 cases

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.

Product Description

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

Distribution Pattern

Nationwide

Other Recalls by O&M HALYARD, INC.

Class II: Risk 07/17/2025

Surgical drape packs may have open seals, which may compromise the sterility of the product.
Class II: Risk 11/26/2024

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.
Class II: Risk 11/08/2024

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.

View all recalls by O&M HALYARD, INC. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.