DuoDERM Extra Thin dressings are highly flexible recalled over foreign material

Recall date

August 29, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ConvaTec, Inc recalls DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exu…

Recall number

Z-0160-2026

FDA classification

Class II

Brand / firm

ConvaTec, Inc

Sold / distributed

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.

Why it was recalled

Wound dressing may have foreign matter on the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.