Genicon, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0310-2021)

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:

A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended

Product Classification:

Class II

Date Initiated: September 17, 2020

Date Posted: November 11, 2020

Recall Number: Z-0310-2021

Event ID: 86412

Reason for Recall:

Device malfunction causing the applier to jam, and clip loading failures.

Status: Ongoing

Product Quantity: 8,872 devices

Code Information:

Model # 360-010-001 (A Li-Gator) lot codes: I8250 I8251 I8252 I8820 I8821 I8822 I8823 I8824 I8825 I9571-A I9572-A I9573-A I9716-A I9717-A I9718-A I9719-A J0113-A J0114-A J0115-A J0225-A J0227-A J0228-A J0229-A J0230-A J0231-A J0240-A J0243-A J0287-A

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of FL, TN, MO, CA, GA, and IN. The countries of Chile, Croatia, Dubai (UAE), Equador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Iraq, Ireland, Israel, Jordan, Kuwait, Lebanon, Malta, Mexico, Morocco, Pakistan, Palestinian, Quatar, Saudi Arabia, Slovenia, South Africa, Switzerland, Tunisia, United Kingdom, and Venezuela.

Voluntary or Mandated:

Voluntary: Firm initiated