---
title: "FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOF... — FDA record Z-2626-2023 | Is It on Recall"
description: "One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user."
url: https://isitonrecall.com/recall/fda-device-z-2626-2023-fluidshield-3-n95-particulate-filter-respirator-and-surgical-mask-with-so-soft-lining-orange-size-sm/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT\* Lining, Orange, size small, Product C... — FDA record Z-2626-2023

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 Aug 9, 2023. 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**: FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT\* Lining, Orange, size small, Product Code 46827
- **Reason**: One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
- **Classification**: Class II
- **Recalling firm**: O&M HALYARD, INC.
- **Quantity**: 41790 masks
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2626-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2626-2023%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: 20680651468271; Lot Number AM2164811 |

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

## Distribution

US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and OUS International to country of: Columbia

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

- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Iowa](https://isitonrecall.com/state/iowa/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [Oklahoma](https://isitonrecall.com/state/oklahoma/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)

## Dates in the source

- **Report date**: Sep 27, 2023
- **Recall initiation date**: Aug 9, 2023
- **Center classification date**: Sep 21, 2023

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-2626-2023%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/)