# FDA recall Z-1534-2018

> **Ethicon, Inc.** · Class II · device recall initiated 2018-03-07.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1534-2018
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-03-07
- **Report date:** 2018-05-02
- **Termination date:** 2019-04-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Somerville, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1534-2018

## Citation

> AI Analytics. FDA recall Z-1534-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1534-2018. Source: US FDA. Licensed CC0.

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