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Lower risk Medical device recall · FDA · Published January 4, 2021

Ethicon Dermabond Adhesive Recall: Sterility Risk from Packaging Tape

Ethicon recalls Dermabond Advanced Topical Skin Adhesive due to potential sterility breach from red packaging tape. Affected units have specific product codes and expiration dates.

🇺🇸 FDA recall #Z-0953-2021Medical deviceEthicon ›
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Recalling firmEthicon, Inc.Us Highway 22 West · Somerville, NJ 08876
✎ GovInfoNow plain-language explainer

Ethicon is recalling Dermabond Advanced Topical Skin Adhesive because the red tape in its sterile packaging might break the seal, risking infection. This affects products with the product code DNX12 and expiration date April 30, 2022. Read more at govinfonow.com/recall/63492-ethicon-dermabond-adhesive-recall-sterility-risk-from-packaging-tape.

Source Summary by GovInfoNow · govinfonow.com/recall/63492-ethicon-dermabond-adhesive-recall-sterility-risk-from-packaging-tape · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0953-2021

Cite this page

“Ethicon Dermabond Adhesive Recall: Sterility Risk from Packaging Tape.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63492-ethicon-dermabond-adhesive-recall-sterility-risk-from-packaging-tape. Based on FDA recall #Z-0953-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0953-2021%22&limit=1).

Ethicon, Inc. voluntarily recalled Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions on Jan. 4, 2021, according to the FDA. The product was distributed with a red tape in its sterile packaging that could impact the seal and result in a sterility breach.

How to tell if you have it

  • Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of
  • UPC: 10705031203532
  • Product Code: DNX12
  • Lot Number: QEBBTQ
  • Exp. Date: April 30, 2022

The hazard

The product was distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach.

Context

GovInfoNow's records show ETHICON, INC. has 25 other recalls on record since 2017-08-17. Other recent recalls include Ethicon Monocryl" Sutures Recall (2024-10-08), Ethicon Coated VICRYL Suture Recall (2024-09-25), and Ethicon Monocryl Plus Suture Recall (2024-05-10). Other recent recalls of similar products include Medline Quick-Strip Bandages Recall (2025-10-27), Covidien Dermalon 4-0 Blue 75cm Sutures Recall (2026-06-24), and Medline Convenience Kits Recall (2026-06-12).

How to tell if you have this one

Check for the product code DNX12 and expiration date April 30, 2022 on the packaging. The adhesive comes in a sterile package with red tape.

  • Brand
    Ethicon
  • Product
    Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for product code DNX12 and expiration date April 30, 2022 on the packaging.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.9 years after the firm started it.

1. Firm started the recall: Jan 4, 202112. FDA classified it Class II: Feb 4, 202123. Published in FDA’s Enforcement Report: Feb 10, 202134. FDA terminated the recall: Nov 29, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0953-2021 (January 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0953-2021 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.
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