Cook Inc.: Medical Device Recall in 2016 - (Recall #: Z-1028-2016)

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:

Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions.

Product Classification:

Class II

Date Initiated: January 8, 2016

Date Posted: March 9, 2016

Recall Number: Z-1028-2016

Event ID: 73083

Reason for Recall:

Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids.

Status: Terminated

Product Quantity: 134

Code Information:

Catalog # DKBL-20-7.0-A Lot # 6215428 date of manufacture 09/17/2015

Distribution Pattern:

Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..

Voluntary or Mandated:

Voluntary: Firm initiated