O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Summary
The FDA issued a Class II for O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical ma by O&M HALYARD, INC.. 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.
Details
Source
Device Recall
External ID
Z-0728-2025
Action Date
2025-01-01
Status
Ongoing
Category
device
Product Description
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117
Lot/Code Info: UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18
Quantity Affected: 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.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-08
Company
Mechanicsville, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 119 device recalls issued in the same week, part of 403 device-related FDA actions this month.
O&M HALYARD, INC. has 24 FDA actions in our database, including 8 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (O&M HALYARD, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does O&M HALYARD, INC. have FDA actions?
O&M HALYARD, INC. has 24 FDA actions in our database, including 8 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0728-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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