Ethicon Dermabond Advanced Topical Skin Adhesive Recalled for Sterility Breach Risk
Ethicon is recalling Dermabond Advanced Topical Skin Adhesive because red tape in the packaging could compromise the sterile seal, potentially leading to a sterility breach.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where a sterility breach could lead to infection, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Ethicon, Inc. is recalling 23,580 units of Dermabond Advanced Topical Skin Adhesive (Product Code: DNX12). The recall is due to a packaging defect where red tape was distributed as part of the sterile packaging. This tape could impact the seal and result in a sterility breach.
The affected product is identified by Lot Number QEBBTQ and has an expiration date of April 30, 2022. The GTIN is 10705031203532. The product was distributed nationwide in the United States.
Dermabond Advanced is a topical skin adhesive used to hold closed easily approximated skin edges of wounds from surgical incisions. Because the defect could compromise sterility, there is a risk of introducing contaminants into the wound site. Healthcare providers and consumers should stop using the affected units and contact Ethicon for further instructions or a return.
The recalled product
- Product
- Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions Product Code: DNX12
- Manufacturer
- Ethicon, Inc.
- Affected units
- 23,580
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: QEBBTQ Exp. Date: April 30
- 2022 GTIN: 10705031203532
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Ethicon, Inc.
See all →- HighEthicon Recalls Monocryl Sutures Due to Component Mix-Up
FDA (Devices) · 2024-11-27
- HighCoated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation
FDA (Devices) · 2024-11-13
- HighVICRYL Sutures recalled due to packaging defect compromising sterility
FDA (Devices) · 2024-06-26
- HighPDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
FDA (Devices) · 2024-06-26
- HighMONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
FDA (Devices) · 2024-06-26
Same hazard · sterility breach
See all →- HighMedline Open Heart A Pack Kits Recalled for Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
- HighMedline Convenience Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline C-Section Prep Kits Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
- SevereMedline Ultrasound Breast Pack Recalled for Potential Sterility Breach
FDA (Devices) · 2026-09-09
Similar recalls
- HighEthicon PSX PROXIMATE Skin Staple Extractor Recalled for Sterility Concerns
FDA (Devices) · 2013-03-13
- ModerateEthicon Recalls DERMABOND PRINEO Skin Closure System Lots
FDA (Devices) · 2018-03-28
- HighSurgical sutures recalled for potential sterility breach
FDA (Devices) · 2025-02-12
- HighEthicon Recalls Proline Sutures Due to Packaging Perforation Risk
FDA (Devices) · 2018-07-25
- HighEthicon Recalls PRONOVA Suture Needles Due to Packaging Perforation Risk
FDA (Devices) · 2018-07-25
- HighEthicon Proceed Surgical Mesh Recalled for Potential Sterility Compromise
FDA (Devices) · 2014-04-09