CooperSurgical, Inc.: Medical Device Recall in 2021 - (Recall #: Z-0260-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220

Product Classification:

Class II

Date Initiated: September 29, 2021

Date Posted: November 24, 2021

Recall Number: Z-0260-2022

Event ID: 88648

Reason for Recall:

Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.

Status: Ongoing

Product Quantity: 75 Units

Code Information:

Serial Numbers: 2018100001 2018100002 2018100003

Distribution Pattern:

US Nationwide Distribution Foreign: ARMENIA, BOLIVIA, CAMBODIA, CANADA, CHILE, CHINA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, ENGLAND, GERMANY, HONG KONG, INDIA, INDONESIA, IRAN, ITALY, JORDAN, KENYA, MALAYSIA, MAURITIUS, MEXICO, NEW ZEALAND, NICARAGUA, NIGERIA, PHILIPPINES, PUERTO RICO, QATAR, RWANDA, SINGAPORE, SOUTH AFRICA, SRI LANKA, TAIWAN, TANZANIA, THAILAND, TRINIDAD, TURKEY, UGANDA, UNITED ARAB EMIRATES, VIETNAM

Voluntary or Mandated:

Voluntary: Firm initiated