Recall
FDAHealthAugust 29, 2025

ConvaTec, Inc — DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly sui

⚠️ Wound dressing may have foreign matter on the product.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
August 29, 2025

US Nationwide distribution including in the states of OH, AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV.

What's affected?

Product
DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exudating wounds. DuoDERM" Extra Thin dressings are particularly suitable in areas subject to friction and those requiring contouring, e.g., elbows, heels. DuoDERM" Extra Thin dressings interact with wound moisture producing a soft mass that enables removal of the dressing with little or no damage to newly formed tissues. They help isolate the wound against bacterial and other external contamination. INDICATIONS " Management of superficial, dry to lightly exudating dermal ulcers. " Post-operative wounds. " Protective dressings.
Lot code
3L04808

Additional details

UDI-DI: 768455150922, Lot: 3L04808

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 80,980.

View original FDA notice →

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