LEEP Precision Integrated System 120V & LEEP Precision Generator
Medical device recall Z-2057-2019. Published in FDA’s Enforcement Report on Jul 31, 2019.
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 Jul 31, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 358 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?
The products’ cut, coagulate, or blend function may not operate with the use of the Foot Pedal.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
LEEP Precision Integrated System 120V & LEEP Precision Generator, Model Nos. LP-10-120 & LP-20-120
358, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot/Serial Numbers: 1214007 2016050014 2016060026 2016080009 2016100021 2017010021 2017050015 2017080013 2015080015 2016050015 2016060027 2016080010 2016100023 2017010023 2017050016 2017080014 2015110007 2016050016 2016060028 2016080011…
Every code shown here, 1,997 characters
Lot/Serial Numbers: 1214007 2016050014 2016060026 2016080009 2016100021 2017010021 2017050015 2017080013 2015080015 2016050015 2016060027 2016080010 2016100023 2017010023 2017050016 2017080014 2015110007 2016050016 2016060028 2016080011 2016100024 2017010024 2017050017 2017080015 2015110019 2016050017 2016060029 2016080012 2016100025 2017020001 2017060001 2017090001 2016030001 2016050018 2016060030 2016080013 2016100026 2017020002 2017060002 2017090003 2016030002 2016050019 2016060031 2016080014 2016100027 2017020003 2017060003 2017090004 2016030003 2016050020 2016070001 2016080015 2016100028 2017020005 2017060004 2017090005 2016030004 2016050021 2016070002 2016080016 2016100029 2017020006 2017060005 2017090006 2016030005 2016050022 2016070003 2016080017 2016100030 2017020007 2017060006 2017090007 2016030006 2016050023 2016070004 2016080018 2016100031 2017020008 2017060007 2017090008 2016030007 2016050024 2016070005 2016080019 2016100032 2017020009 2017060008 2017090009 2016030008 2016050025 2016070006 2016080020 2016100033 2017020010 2017060009 2017090010 2016030009 2016050027 2016070007 2016080021 2016100034 2017020011 2017060010 2017090011 2016030010 2016050028 2016070008 2016080022 2016100035 2017020012 2017060011 2017090012 2016030011 2016050029 2016070009 2016080023 2016120001 2017020013 2017060012 2017090014 2016030012 2016050030 2016070010 2016080024 2016120002 2017020014 2017060013 2017110002 2016030013 2016050031 2016070011 2016080025 2016120003 2017020015 2017060014 2017110003 2016030014 2016050032 2016070012 2016080026 2016120004 2017020017 2017060015 2017110004 2016030015 2016050033 2016070013 2016080027 2016120005 2017020018 2017070001 2017110005 2016030016 2016050034 2016070014 2016080029 2016120006 2017020019 2017070002 2017110006 2016030017 2016060001 2016070015 2016080030 2016120007 2017020020 2017070003 2017110007 2016040001 2016060002 2016070016 2016080031 2016120008 2017040001 2017070004 2017110008 2016040002 2016060003 2016070017 2016080032…
FDA’s list runs to 3,954 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.
Nationwide domestic distribution. International distribution to Canada and Costa Rica.
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?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Jun 18, 2019.
- FDA classified it on Jul 23, 2019.
- FDA’s Enforcement Report published it on Jul 31, 2019.
- FDA terminated it on Jun 15, 2020.
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 3,954 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.