Recall Z-0728-2025— O&M HALYARD, INC.

Name: FDA recall Z-0728-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-08

Class II · Ongoing

Class II FDA medical device recall by O&M HALYARD, INC., initiated 2024-11-08. It names 2 FDA 510(k) clearances: K831148, K823078. Product: O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117. Reason: 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..

Recalling firm: O&M HALYARD, INC.
Classification: Class II
Status: Ongoing
Initiated: 2024-11-08
Firm location: Mechanicsville, VA, United States

510(k) clearances named in this recall

2 on FDA's record

K831148 — HIGH FILTRATION ISO-MASKTecnol New Jersey Wound Care, Inc.·cleared 1984-07-17
K823078 — SPUNGUARD FACE MASKKimberly-Clark Corp.·cleared 1983-01-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.