Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-0971-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Urethral Dilator Set, Global Product No. G14185

Product Classification:

Class II

Date Initiated: January 4, 2019

Date Posted: February 12, 2020

Recall Number: Z-0971-2020

Event ID: 82026

Reason for Recall:

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Status: Terminated

Product Quantity: 13388 total

Code Information:

8401849 8404945 8404946 8417702 8404946X

Distribution Pattern:

Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated