O&M HALYARD, INC.: Medical Device Recall in 2025 - (Recall #: Z-0728-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 8, 2024

Date Posted: January 1, 2025

Recall Number: Z-0728-2025

Event ID: 95804

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.

Status: Ongoing

Product Quantity: 211 cases

Code Information:

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

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated