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LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220

FDA Device Recall #Z-0258-2022 — Class II — September 29, 2021

Recall Summary

Recall Number Z-0258-2022
Classification Class II — Moderate risk
Date Initiated September 29, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CooperSurgical, Inc.
Location Trumbull, CT
Product Type Devices
Quantity 75 Units

Product Description

LEEP PRECISION Integrated System, 220V CooperSurgical part numbers: LP-10-220

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.

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

Lot / Code Information

Serial Numbers: 2017040001 2017040002 2017040003 2017040004 2017040005 2018030001 2018030002 2018030003 2018030004 2018100004 2018100005 2018100006 2018120001 2018120002 2018120003 2019010001 2019010002 2019010003 2019010004 2019010005 2019030001 2019030002 2019030003 2019030004 2019070001 2019070002 2019070003 2019070004 2019070005 2019070006 2019100001 2019100004 2019100005 2019120001 2019120002 2019120003 2019120004 2019120005 2019120006 2020030001 2020030002 2020030003 2020030004 2020030005 2020060001 2020060002 2020060003 2020060004 2020060005 2020060006 2020080001 2020080002 2020080003 2020080004 2020080005 2020080006 2020110001 2020110002 2020110003 2020110004 2020110005 2020110006 2020120001 2020120002 2020120003 2020120004 2020120005 2020120006 2021010001 2021010002 2021010003 2021010004 2021010005

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Z-2137-2025 Class II Endosee System Convenience Kit with IV Tube. Mo... Jun 11, 2025
Z-0687-2025 Class II Brand Name: K-Systems Product Name: G73 Dry Ba... Nov 15, 2024
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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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