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.
This recall is currently active, issued October 16, 2025. It was issued by Convatec, Inc.
- Company
- Convatec, Inc
- Recall Initiated
- August 29, 2025
- Posted
- October 16, 2025
- Recall Number
- Z-0160-2026
- Quantity
- 80,980
- Firm Location
- Greensboro, NC
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
UDI-DI: 768455150922, Lot: 3L04808
Root Cause
Process control
Action Taken
On 8/29/2025, Recall Notices were emailed to customers who were asked to do the following: 1) Quarantine and stop distribution of affected stock. 2) Notify downstream recipients of this product. 3) Confirm receipt of this notice via survey link and ensure all affected inventory is identified, managed, and where applicable destroyed. Questions can be directed to the firm at: us.customerservice@convatec.com