DUODERM recallZ-0160-2026 · ConvaTec, Inc · initiated Aug 29, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ConvaTec, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Wound dressing may have foreign matter on the product.
FDA root cause category: Process control
What the company is doing
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: [email protected]
Recall details
- Recall number
- Z-0160-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 29, 2025
- Posted by the FDA
- Oct 16, 2025
- Recalling firm
- ConvaTec, Inc
- Quantity
- 80,980
- Product code
- NAD
- 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.
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.
Code information (models, lots, serial numbers)
UDI-DI: 768455150922, Lot: 3L04808
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DUODERM 187955Convatec, Purchasing Department · Dressing, Wound, Occlusive1 recall2,348 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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