DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed for use on dry to lightly exud
FDA device recall Z-0160-2026 · posted 2025-10-16 · Open, Classified
Recall details
- Recalling firm
- ConvaTec, Inc
- Reason for recall
- Wound dressing may have foreign matter on the product.
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- NAD
- Quantity affected
- 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
- Date initiated
- 2025-08-29
- Date posted
- 2025-10-16
- Location
- Greensboro, NC
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