CooperSurgical, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1840-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

LEEP Precision Integrated System 120V, Model LP-10-120 Product Usage: The LEEP PRECISION INTEGRATED SYSTEM l 20V combines three components - LEEP PRECISION Cart, LEEP PRECISION Generator, and the LEEP PRECISION Smoke Evacuator for loop electrosurgical excision procedures. The loop electrosurgical excision procedure (LEEP) utilizes a very thin wire in the shape of a loop heated by electrical current generated by a power supply to efficiently remove abnormal cells. The LEEP PRECISION INTEGRATED SYSTEM has been designed to provide an efficient workstation that can efficiently meet all the unique LEEP requirements of the clinic and practice-based facilities .

Product Classification:

Class II

Date Initiated: April 23, 2019

Date Posted: June 26, 2019

Recall Number: Z-1840-2019

Event ID: 82821

Reason for Recall:

2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses.

Status: Terminated

Product Quantity: 19

Code Information:

2018110001,2018110002, 2018110003, 2018110004, 2018110005,2018110006, 2018110007, 2018110008,2018110011, 2018110012,2018110013, 2018110014, 2018110015,2018110016, 2018110017, 2018110019, 2018110020,2018110021,& 2018110022

Distribution Pattern:

US Nationwide Distribution in the states of CA, CT, IN, MA, MI, MN, NC, NV, NY, OH, TX, WA and WI.

Voluntary or Mandated:

Voluntary: Firm initiated