Teleflex Medical: Medical Device Recall in 2016 - (Recall #: Z-0764-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures.

Product Classification:

Class II

Date Initiated: November 18, 2016

Date Posted: December 21, 2016

Recall Number: Z-0764-2017

Event ID: 75735

Reason for Recall:

Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.

Status: Terminated

Product Quantity: 96,402 units (9,120 ea US, 87,282 ea OUS)

Code Information:

Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.

Distribution Pattern:

Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated