Evicel Accessory Device — Class II medical device recall Z-1534-2018
Terminated recall by Ethicon, Inc., reported 2018-05-02, distributed in AK, AL, AR, AZ, CA, CO, FL, GA…. Products labeled for distribution outside the United States may have been distributed to customers in the Unit
| Recall number | Z-1534-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2018-03-07 |
| Classified | 2018-04-26 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2019-04-30 |
| Distributed | AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, PR, TN, TX, WA, WI, WV |
| Reason classes | labeling |
| Lot numbers | 17-0102 |
Product
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45. Accessory Tips for use only with EVICEL Fibrin Sealant (Human) Application Device.
Reason for recall
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
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-1534-2018. 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.