DuoDERM Dressings (ConvaTec) – Foreign Matter Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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 exte
Brand
ConvaTec, Inc
Lot Codes / Batch Numbers
UDI-DI: 768455150922, Lot: 3L04808
Products Sold
UDI-DI: 768455150922, Lot: 3L04808
ConvaTec, Inc is recalling DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on due to Wound dressing may have foreign matter on the product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Wound dressing may have foreign matter on the product.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026