---
title: "O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical... — FDA record Z-0728-2025 | Is It on Recall"
description: "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"
url: https://isitonrecall.com/recall/fda-device-z-0728-2025-o-m-halyard-procedure-mask-with-so-soft-earloops-yellow-disposable-surgical-mask-product-code-47117/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# O&M Halyard Procedure Mask with SO SOFT\* Earloops, Yellow-Disposable surgical mask Product Code: 47117 — FDA record Z-0728-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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.
- **Classification**: Class II
- **Recalling firm**: O&M HALYARD, INC.
- **Quantity**: 211 cases
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0728-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0728-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 20680651471172 Lot Number: AM4049121 Exp. Date: 2029-02-18 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Nationwide

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

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## Dates in the source

- **Report date**: Jan 1, 2025
- **Recall initiation date**: Nov 8, 2024
- **Center classification date**: Dec 20, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0728-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [O&M HALYARD, INC. records](https://isitonrecall.com/brand/o-m-halyard-inc/)