Cook Inc.: Medical Device Recall in 2017 - (Recall #: Z-2536-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Stamey Needle

Product Classification:

Class II

Date Initiated: April 25, 2017

Date Posted: June 21, 2017

Recall Number: Z-2536-2017

Event ID: 77217

Reason for Recall:

reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products

Status: Terminated

Product Quantity: 698

Code Information:

All lots Catalog numbers: 095000; 095015; 095030; J-SYN-931600; J-SYN-931615; J-SYN-931630

Distribution Pattern:

The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated