3B Medical Ultrasoft Oxygen Cannulas Recalled for Use Past Expiration Date

Agency Publication Date: January 8, 2025

Summary

3B Medical, Inc. has recalled 5,010 units of its Ultrasoft Oxygen Cannula (12 Foot) because the devices were inadvertently shipped to distributors after their expiration date. These nasal cannulas are intended for use with oxygen concentrators to deliver supplemental oxygen to patients. Consumers should check their supplies for model O2U2012 with lot number 20170403.

Risk

Using a medical device past its expiration date can lead to degraded materials or a loss of sterility, which may result in infections or decreased performance during oxygen therapy. No incidents or injuries have been reported to date.

What You Should Do

This recall affects 3B Medical, Inc. Ultrasoft Oxygen Cannulas (12 Foot) with model/catalog number O2U2012 and lot number 20170403.
Check the product label or packaging to identify if your device has model number O2U2012 and lot number 20170403.
Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or 3B Medical, Inc. for further instructions.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement

Option 2: Dispose of Product

How to: Stop using and throw the product away.

Affected Products

Product: Ultrasoft Oxygen Cannula (12 Foot)

Variants: 12 Foot

Model / REF:

O2U2012

Lot Numbers:

20170403

Nasal Cannulas for use with Oxygen Concentrators. Recall #: Z-0828-2025.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95918

Status: Active

Manufacturer: 3B Medical, Inc.

Sold By: medical equipment distributors

Manufactured In: United States

Units Affected: 5010 units

Distributed To: Massachusetts, Arkansas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 3B Medical, Inc. Ultrasoft Oxygen Cannulas (12 Foot) with model/catalog number O2U2012 and lot number 20170403.

Check the product label or packaging to identify if your device has model number O2U2012 and lot number 20170403.

Stop using the product. Return it to the place of purchase for a refund or replacement, throw it away, or contact your healthcare provider or 3B Medical, Inc. for further instructions.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.