Device recall

Z-0160-2026: DuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings…

FDA device recall · Class II · ConvaTec, Inc

Key facts

Recall number (Z-number) Z-0160-2026
Recall event 97445
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…
Product code NAD
Recalling firm ConvaTec, Inc
Recall class Class II
Status Open, Classified
FEI number 3011987967

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)