ConvaTec, Inc: Medical Device Recall in 2025 - (Recall #: Z-0160-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 29, 2025

Date Posted: October 22, 2025

Recall Number: Z-0160-2026

Event ID: 97445

Reason for Recall:

Wound dressing may have foreign matter on the product.

Status: Ongoing

Product Quantity: 80,980

Code Information:

UDI-DI: 768455150922, Lot: 3L04808

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated