ConvaTec, Inc: Device Recall

Recall #Z-0160-2026 · 08/29/2025

Class II: Risk

Recall Details

Recall Number: Z-0160-2026
Classification: Class II
Product Type: Device
Recalling Firm: ConvaTec, Inc
Status: Ongoing
Date Initiated: 08/29/2025
Location: Greensboro, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 80,980

Reason for Recall

Wound dressing may have foreign matter on the product.

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.

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.

Other Recalls by ConvaTec, Inc

Class II: Risk 11/29/2024

Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding

View all recalls by ConvaTec, Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.