Recall Z-0160-2026 ยท NAD Dressing, Wound, Occlusive
ConvaTec, Inc
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 littl
| Date | Oct 16, 2025 (initiated Aug 29, 2025) |
| Status | Open, Classified |
| Reason | Wound dressing may have foreign matter on the product. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 80,980 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.