FDA Device recall Z-1534-2018
Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Evicel Accessory Device - 45 cm Flexible Tip (SET OF 3), Product Code EVT45 by Ethicon, citing products labeled for distribution outside the United States may have been distributed to customers in the United States.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1534-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-07 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ethicon |
| Distribution | 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 |
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
Products labeled for distribution outside the United States may have been distributed to customers in the United States.
Identifiers
| code_info | Lot 17-0102 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1534-2018%22
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