Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin… — Class II medical device recall Z-0953-2021
Terminated recall by Ethicon, Inc., reported 2021-02-10, distributed nationwide. Product distributed with a red tape as part of the sterile packaging which could impact the seal and result in
| Recall number | Z-0953-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2021-01-04 |
| Classified | 2021-02-04 |
| Reported by FDA | 2021-02-10 |
| Terminated | 2023-11-29 |
| Distributed | Nationwide (US) |
| Quantity | 23,580 eaches |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 10705031203532 |
| Expiration dates | 2022-04-30 |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0953-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.