ConvaTec recalls DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk) due to possible incorrect primary packaging labeling. Affected items have Lot Number 8G03458 and expire July 2023.
“ConvaT: DuoDERM Border Dressings Recall - Incorrect Labeling Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61916-convat-duoderm-border-dressings-recall-incorrect-labeling-hazard. Based on FDA recall #Z-2614-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2614-2021%22&limit=1).
The FDA announced on Aug. 20, 2021, that ConvaTec, Inc is recalling DuoDERM Control Gel Formula Border Dressings because primary packaging labeling may be incorrect. Owners should contact the company for a remedy.
How to tell if you have it
Brand: ConvaTec
Product: DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Lot Number: 8G03458
Expiry: Jul 2023
Quantity: 170 packs
The hazard
The primary packaging labeling may be incorrect, according to the FDA.
Context
GovInfoNow's records show ConvaTec, Inc has had 17 other recalls since Oct. 26, 2017. Recent brand recalls include ConvaTec Esteem Body Soft Urostomy Pouches (July 6, 2026) and ConvaTec Aquacel Ag Surgical SP Dressings (June 8, 2026). Other recent recalls of similar products include MediHoney Gel Dressing (Jan. 16, 2026), KOB MEDLINE UNNA-Z Stretch Zinc Paste Bandage (Jan. 15, 2026), and Integra CVS Wound Dressing (Jan. 16, 2026).
How to tell if you have this one
Check for the lot number 8G03458 on the primary packaging of DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk). The product expires in July 2023.
Brand
ConvaTec
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Packaging Details
Verify the lot number on the primary packaging to confirm if it matches 8G03458.
Where it went and when
Where it was distributed
Distributed in 13 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC. NM, NJ, OH, PA, TX, VA” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Georgia, Illinois, Maryland, Minnesota, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, Texas, Virginia.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2614-2021 (August 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2614-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.