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.
What this means for you
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
- 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
- HighPDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
FDA (Devices) · 2024-06-26
Same hazard · sterility breach
See all →- ModerateMedline Kits with Zimmer Biomet Mixing Bowls and Spatulas Recalled
FDA (Devices) · 2026-07-22
- ModerateMedline Kits with Zimmer Biomet Mixing Bowls Recalled for Seal Defects
FDA (Devices) · 2026-07-22
- HighIntracept Access Instruments sterile barrier breach risk
FDA (Devices) · 2026-07-15
- ModerateSterile Tourniquet Hoses recalled for potential sterility breach
FDA (Devices) · 2026-07-08
- ModerateSterile Tourniquet Hoses Recalled Due to Potential Sterility Breach
FDA (Devices) · 2026-07-08