---
title: "Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot ... — FDA record Z-0828-2025 | Is It on Recall"
description: "The devices were inadvertently shipped after their expiration date."
url: https://isitonrecall.com/recall/fda-device-z-0828-2025-brand-name-3b-medical-inc-product-name-ultrasoft-oxygen-cannula-12-foot-model-catalog-number-o2u2012/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Numb... — FDA record Z-0828-2025

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 27, 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**: Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators
- **Reason**: The devices were inadvertently shipped after their expiration date.
- **Classification**: Class II
- **Recalling firm**: 3B Medical, Inc.
- **Quantity**: 5010 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0828-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0828-2025%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 | Lot Code: Lot Number 20170403 |

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

## Distribution

US: Massachusetts and Arkansas OUS: None

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

- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)

## Dates in the source

- **Report date**: Jan 15, 2025
- **Recall initiation date**: Nov 27, 2024
- **Center classification date**: Jan 8, 2025

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-0828-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [3B Medical, Inc. records](https://isitonrecall.com/brand/3b-medical-inc/)