O&M HALYARD, INC.: FLUIDSHIELD N95 Respirators Recalled for Filtration Efficiency Failure

Agency Publication Date: September 21, 2023

Summary

O&M HALYARD, INC. is recalling approximately 41,790 FLUIDSHIELD 3 N95 Particulate Filter Respirators and Surgical Masks (size small, orange color) because a sample failed a filtration efficiency test. This defect means the masks may not provide the level of respiratory protection intended for the user, especially in medical environments. The affected masks were distributed to eleven U.S. states and internationally to Columbia. If you have these masks, you should contact your healthcare provider or the manufacturer for further instructions regarding the recall.

Risk

The respirator failed to meet filtration efficiency standards, meaning it may allow airborne particles or contaminants to pass through the mask. This exposes the user to an increased risk of inhaling harmful particles or pathogens they would otherwise expect to be filtered out.

What You Should Do

Check your respirator packaging for the product name 'FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining' in orange, size small.
Verify the identifying codes on the packaging: look for Product Code 46827, UDI-DI 20680651468271, and Lot Number AM2164811.
If your masks match Lot Number AM2164811, stop using them immediately to ensure your safety.
Contact your healthcare provider or O&M HALYARD, INC. for specific instructions on how to handle the affected masks and to inquire about a potential refund or replacement.
For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit their website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer and Healthcare consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small

Model / REF:

Product Code 46827

UDI-DI: 20680651468271

Lot Numbers:

AM2164811

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92942

Status: Active

Manufacturer: O&M HALYARD, INC.

Sold By: Medical distributors

Manufactured In: United States

Units Affected: 41790 masks

Distributed To: Florida, Georgia, Iowa, Illinois, Missouri, Mississippi, Nebraska, Oklahoma, Tennessee, Texas, Wisconsin

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

Check your respirator packaging for the product name 'FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining' in orange, size small.

Verify the identifying codes on the packaging: look for Product Code 46827, UDI-DI 20680651468271, and Lot Number AM2164811.

If your masks match Lot Number AM2164811, stop using them immediately to ensure your safety.

Contact your healthcare provider or O&M HALYARD, INC. for specific instructions on how to handle the affected masks and to inquire about a potential refund or replacement.

For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit their website at www.fda.gov/medical-devices/medical-device-recalls.