CLASS II Device recall · Reported 10 Feb 2021 · FDA Enforcement Report
Dermabond Advanced Topical Skin Adhesive-topical skin recalled
Ethicon is recalling Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily, distributed nationwide in the US. The recall was initiated on 4 Jan 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0953-2021
- FDA event ID
- 87088
- Recalling firm
- Ethicon, Somerville, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Jan 2021
- FDA classified
- 4 Feb 2021
- Reported
- 10 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 4 Jan 2021 | Recall initiated by company | |
| 4 Feb 2021 | Classified by FDA | +31 days |
| 10 Feb 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in a sterility breach
Which lots are affected?
Lot Number: QEBBTQ Exp. Date: April 30, 2022 GTIN: 10705031203532
Where was it sold?
US Nationwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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