# FDA recall Z-0160-2026

> **ConvaTec, Inc** · Class II · device recall initiated 2025-08-29.

## 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 external contamination.     INDICATIONS   " Management of superficial, dry to lightly exudating dermal ulcers.   " Post-operative wounds.   " Protective dressings.

## Reason for recall

Wound dressing may have foreign matter on the product.

## 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.

## Key facts

- **Recall number:** Z-0160-2026
- **Recalling firm:** ConvaTec, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-29
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Greensboro, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0160-2026

## Citation

> AI Analytics. FDA recall Z-0160-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0160-2026. Source: US FDA. Licensed CC0.

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