DuoDERM Extra Thin Dressings Recalled for Potential Foreign Matter

Agency Publication Date: October 16, 2025

Summary

ConvaTec, Inc. is recalling 80,980 DuoDERM Extra Thin dressings because the products may contain foreign matter. These highly flexible, gel-formula dressings are intended for use on dry to lightly oozing wounds, including superficial ulcers and post-operative sites. Consumers should stop using dressings from the affected lot immediately to avoid potential complications.

Risk

The presence of foreign matter on a wound dressing can lead to wound contamination, irritation, or infection. This may delay the healing process or cause further injury to newly formed tissue in the affected area.

What You Should Do

This recall affects DuoDERM Extra Thin dressings, which are flexible, gel-formula wound dressings typically used on areas prone to friction like elbows and heels.
Check your product packaging for Lot number 3L04808 and Unique Device Identifier (UDI-DI) 768455150922.
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 ConvaTec, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

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: DuoDERM Extra Thin Dressings

Lot Numbers:

3L04808

UDI:

768455150922

Quantity: 80,980 units

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97445

Status: Active

Manufacturer: ConvaTec, Inc

Manufactured In: United States

Units Affected: 80,980

Distributed To: Ohio, Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia

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 DuoDERM Extra Thin dressings, which are flexible, gel-formula wound dressings typically used on areas prone to friction like elbows and heels.

Check your product packaging for Lot number 3L04808 and Unique Device Identifier (UDI-DI) 768455150922.

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 ConvaTec, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.