Z-0260-2022Class II

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

Name: Z-0260-2022 LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Creator: CooperSurgical, Inc.
Published: 2021-09-29
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2021-09-29 / Open, Classified / root cause: design

FDA source

CooperSurgical, Inc. began a recall of LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220 on 2021-09-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0260-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-09-29
Posted: 2021-11-18
Recalling firm: CooperSurgical, Inc.
Product: LEEP PRECISION Generator 220V Cooper Surgical Part Number: LP-20-220
Product code: HGI Electrocautery, Gynecologic (And Accessories)
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: CooperSurgical issued Urgent Medical Device Recall to consignees via certified mail with confirmed delivery receipt dated 9/29/21. Letter states reason for recall, health risk and action to take: This Recall affects 2955 units manufactured since product launch in December 2009 and a corrective action has been initiated to prevent future recurrence. Please discontinue use of this product, quarantine the product, and complete the attached Acknowledgement and Receipt Form to arrange for repair of your device at CooperSurgical s expense, including shipping, and return of the product to you. Please feel free to reach us at 203-601-5200 ext. 3300. Please complete this form and return it via email: [email protected] or fax to 203.601.9870 ATTN: Product Surveillance. CooperSurgical will arrange for a product repair after this form has been received. Firm issued additional letter for the product LP-10-220 as it was not included in the initial recall letter. The letter dated 10/18/21 distributed to international accounts only.
Quantity in commerce: 75 Units
Distribution: 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
Product codes and lots: Serial Numbers: 2018100001 2018100002 2018100003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0260-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0257-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0258-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0259-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0260-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0261-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0262-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-18
Z-0263-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-11-24	2021-11-18

Product code HGI

K963653Class IIWallach Quantum 2000 Electrosurgical SystemWallach Surgical Devices, Inc. / cleared 1997-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)