LEEP PRECISION Generator 120V Cooper Surgical
Medical device recall Z-0259-2022. Published in FDA’s Enforcement Report on Nov 24, 2021.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 24, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 244 Units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
LEEP PRECISION Generator 120V Cooper Surgical Part Number: LP-20-120
244 Units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 0215002 1214007 2015050001 2016060030 2016060031 2016070002 2016070004 2016070012 2016070017 2016070021 2016070022 2016070026 2016070027 2016070028 2016070030 2016070031 2016080002 2016080004 2016080007 2016080009…
Every code shown here, 1,990 characters
Serial Numbers: 0215002 1214007 2015050001 2016060030 2016060031 2016070002 2016070004 2016070012 2016070017 2016070021 2016070022 2016070026 2016070027 2016070028 2016070030 2016070031 2016080002 2016080004 2016080007 2016080009 2016080015 2016080016 2016080017 2016080018 2016080019 2016080020 2016080021 2016080022 2016080025 2016080026 2016080027 2016080029 2016080031 2016080033 2016080034 2016080035 2016080036 2016100002 2016100004 2016100009 2016100010 2016100012 2016100013 2016100014 2016100016 2016100017 2016100018 2016100021 2016100023 2016100024 2016100025 2016100027 2016100028 2015050016 2015050017 2015050018 2015050019 2015050020 2015110007 2016030001 2016030002 2016030006 2016030007 2016030013 2016030015 2016040001 2016040002 2016040004 2016040006 2016040007 2016040010 2016050004 2016050006 2016050007 2016050010 2016050012 2016050013 2016050015 2016050016 2016050019 2016050029 2016050031 2016050034 2016060001 2016060002 2016060003 2016060004 2016060006 2016060007 2016060009 2016060012 2016060013 2016060016 2016060021 2016060022 2016060023 2016060025 2016060026 2016060028 2016060029 2016100029 2016100033 2016100034 2016100035 2016120002 2016120003 2016120004 2016120005 2016120008 2016120010 2016120011 2017010001 2017010002 2017010003 2017010004 2017010005 2017010006 2017010007 2017010009 2017010010 2017010011 2017010012 2017010015 2017010016 2017010018 2017010020 2017010023 2017020001 2017020002 2017020003 2017020004 2017020005 2017020006 2017020008 2017020011 2017020012 2017020013 2017020014 2017020017 2017020019 2017040001 2017040002 2017040003 2017040005 2017040008 2017040015 2017050008 2017050012 2017050013 2017050014 2017050015 2017050016 2017050017 2017060003 2017060004 2017060006 2017060010 2017060011 2017060012 2017060013 2017060014 2017060015 2017070002 2017070003 2017070005 2017070006 2017070009 2017070010 2017070012 2017070013 2017070015 2017080001 2017080003 2017080004 2017080005 2017080007 2017080010 2017080011 2017080015 2017090001…
FDA’s list runs to 2,506 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 29, 2021.
- FDA classified it on Nov 18, 2021.
- FDA’s Enforcement Report published it on Nov 24, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CooperSurgical, Inc., of Trumbull, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,506 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.