Terumo Medical Corp: Medical Device Recall in 2018 - (Recall #: Z-2337-2018)

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:

Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135

Product Classification:

Class II

Date Initiated: April 9, 2018

Date Posted: July 11, 2018

Recall Number: Z-2337-2018

Event ID: 80242

Reason for Recall:

Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.

Status: Terminated

Product Quantity: 240

Code Information:

5980075, 5980077

Distribution Pattern:

Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.

Voluntary or Mandated:

Voluntary: Firm initiated