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Lower risk Medical device recall · FDA · Published November 15, 2022

ConvaTec AQUACEL Foam Adhesive Recall: Brown Spots in Wound Dressings

ConvaTec recalls AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to brown spots found on some dressings. Affected units have REF 420861, Batch 1C03858, expiring 01 Mar 2023.

🇺🇸 FDA recall #Z-0723-2023Medical deviceConvaTec ›
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Recalling firmConvaTec, Inc7815 National Service Rd Ste 600 · Greensboro, NC 27409-9403
✎ GovInfoNow plain-language explainer

What happened, in plain English

ConvaTec is recalling a batch of AQUACEL Foam Ag Adhesive wound dressings because they contain brown spots. This contamination could lead to infection or irritation if used on wounds. Read more at govinfonow.com/recall/59374-convatec-aquacel-foam-adhesive-recall-brown-spots-in-wound-dressings.

Source Summary by GovInfoNow · govinfonow.com/recall/59374-convatec-aquacel-foam-adhesive-recall-brown-spots-in-wound-dressings · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0723-2023

Cite this page

“ConvaTec AQUACEL Foam Adhesive Recall: Brown Spots in Wound Dressings.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59374-convatec-aquacel-foam-adhesive-recall-brown-spots-in-wound-dressings. Based on FDA recall #Z-0723-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0723-2023%22&limit=1).

Why it’s dangerous

Brown spots in the adhesive could cause irritation or infection when applied to wounds. The contamination is visible but not harmful in normal use.

Who’s affected

Wound care users who purchased the specific batch (REF 420861, Batch 1C03858) from the manufacturer. People with open wounds are most at risk of infection.

How to tell if you have this one

Check for brown spots on the adhesive. Affected units have REF number 420861 and Batch 1C03858, expiring 01 March 2023.

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

What to do — step by step

  1. Check for Brown Spots

    Inspect the adhesive for visible brown spots. If found, do not use the dressing.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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

Distributed nationwide.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Nov 15, 202212. FDA classified it Class II: Dec 19, 202223. Published in FDA’s Enforcement Report: Dec 28, 202232022
  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.

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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-0723-2023 (November 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0723-2023 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.
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