FDA recall Z-0160-2026

ConvaTec, Inc · Class II · device

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.

Reason for recall

Wound dressing may have foreign matter on the product.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2025-08-29
Report date
2025-10-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Greensboro, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2026