Class II — Ethicon, Inc.
| Recalling firm | ETHICON INC. |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Products labeled for distribution outside the United States may have been distributed to customers in the United States. |
| 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. |
| Quantity | 738 devices (246 boxes of 3) |
| Distribution | The device was distributed to the following states: AK, AL, AR, AZ, CA, CO, FL, GA, IA, IL MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, PA, TN, TX, WA, WI, and WV. The device was also distributed to Puerto Rico. |
| Initiated | 2018-03-07 |
| Classified | 2018-04-26 |
| Terminated | 2019-04-30 |
| Recall number | Z-1534-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ethicon, Inc. (Z-1534-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79668/
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