Ethicon, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1534-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 7, 2018

Date Posted: May 2, 2018

Recall Number: Z-1534-2018

Event ID: 79668

Reason for Recall:

Products labeled for distribution outside the United States may have been distributed to customers in the United States.

Status: Terminated

Product Quantity: 738 devices (246 boxes of 3)

Code Information:

Lot 17-0102

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated