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Lower risk Medical device recall · FDA · Published August 29, 2025

ConvaTec DuoDERM Extra Thin Dressings Recall: Foreign Matter Hazard

ConvaTec recalls DuoDERM Extra Thin dressings due to potential foreign matter. These flexible wound dressings may contain impurities that could affect wound healing. Consumers should check product labels for UDI-DI 768455150922 and lot 3L04808.

🇺🇸 FDA recall #Z-0160-2026Medical deviceConvaTec ›
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Contact the company

Recalling firmConvaTec, Inc7815 National Service Rd Ste 600 · Greensboro, NC 27409-9403
✎ GovInfoNow plain-language explainer

What happened, in plain English

ConvaTec is recalling DuoDERM Extra Thin dressings because they may have foreign matter. This could lead to infection or delayed healing if the dressing isn't clean. Affected customers should check their product labels for the specific UDI-DI and lot number. Read more at govinfonow.com/recall/51519-convatec-duoderm-extra-thin-dressings-recall-foreign-matter-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/51519-convatec-duoderm-extra-thin-dressings-recall-foreign-matter-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0160-2026

Cite this page

“ConvaTec DuoDERM Extra Thin Dressings Recall: Foreign Matter Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51519-convatec-duoderm-extra-thin-dressings-recall-foreign-matter-hazard. Based on FDA recall #Z-0160-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0160-2026%22&limit=1).

Why it’s dangerous

The dressings may contain foreign matter that could introduce infection or delay healing. This is especially concerning for wounds that are dry or lightly exuding fluid.

Who’s affected

People using DuoDERM Extra Thin dressings for dry to lightly exudating wounds are affected. Those with open wounds or recent surgeries are most at risk.

How to tell if you have this one

Check the product label for UDI-DI 768455150922 and lot number 3L04808. These dressings are designed for dry to lightly exudating wounds and are used on areas like elbows and heels.

  • Brand
    ConvaTec
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the UDI-DI number 768455150922 and lot number 3L04808 on the dressing packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 42 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Aug 29, 202512. FDA classified it Class II: Oct 16, 202523. Published in FDA’s Enforcement Report: Oct 22, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Can I still use these dressings?

Yes, but you should check the label first. If the UDI-DI and lot number match the recalled items, contact ConvaTec for advice.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0160-2026 (August 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0160-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA