Recall Z-0160-2026— ConvaTec, Inc
Class II · Ongoing
Class II FDA medical device recall by ConvaTec, Inc, initiated 2025-08-29. FDA's recall record names no specific 510(k) clearance for this event. 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: Wound dressing may have foreign matter on the product..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-29
- Firm location
- Greensboro, NC, United States
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.
Reason for recall
Wound dressing may have foreign matter on the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.