Quantum 2000 Electrosurgical Generators Cooper Surgical
Medical device recall Z-0262-2022. 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
- 700 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?
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05
700 Units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 0209001 0209002 0209003 0209004 0211001 0211002 0211003 0211004 0211005 0211006 0211007 0211008 0211009 0211010 0211011 0211012 0211013 0211014 0211015 0211016 0211017 0211018 0211019 0211020 0211021 0211022 0211023 0211024…
Every code shown here, 1,999 characters
Serial Numbers: 0209001 0209002 0209003 0209004 0211001 0211002 0211003 0211004 0211005 0211006 0211007 0211008 0211009 0211010 0211011 0211012 0211013 0211014 0211015 0211016 0211017 0211018 0211019 0211020 0211021 0211022 0211023 0211024 0211025 0211026 0211027 0211028 0211029 0211030 0211031 0211032 0211033 0211034 0211035 0211036 0211037 0211038 0211039 0211040 0215001 0215002 0215003 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0215012 0215013 0215014 0215015 0215016 0215017 0215018 0215019 0215020 0215021 0215022 0215023 0215024 0215025 0215026 0215027 0215028 0215029 0215030 0215031 0215032 0215033 0215034 0215035 0215036 0314014 0314014KF 0314019 0410001 0410002 0410003 0410004 0410005 0410006 0410007 0410008 0410009 0410010 0410011 0410012 0410013 0410014 0410015 0410016 0410017 0410018 0410019 0410020 0410021 0410022 0410023 0410024 0410025 0410026 0410027 0410028 0410029 0410030 0410031 0410032 0410033 0410034 0410035 0410036 0410037 0410038 0410039 0410040 0414009 0414010 0414011 0414013 0414015 0414016 0414019 0414021 0414023 0414024 0510001 0510002 0510003 0510004 0612001B 0612002B 0612003B 0612003BTP 0612004B 0612005B 0612006B 0612007B 0612008B 0612008BTP 0612009B 0612010B 0612011B 0612012B 0612013B 0612014B 0612015B 0612016B 0612017B 0612018B 0612019B 0612020B 0612021B 0612022B 0612023B 0612024B 0612025B 0612026B 0612027B 0612028B 0612029B 0612030B 0612031B 0612032B 0612033B 0612034B 0612035B 0612036B 0612037B 0612038B 0612039B 0612040B 0613001C 0613002C 0613003C 0613004C 0613005C 0613006C 0613007C 0613008C 0613009C 0613010C 0613011C 0613012C 0613013C 0613014C 0613015C 0613016C 0613017C 0613018C 0613019C 0613020C 0613021C 0613022C 0613023C 0711001 0711002 0711003 0711004 0711005 0711006 0711007 0711008 0711009 0711010 0711011 0711012 0711013 0711014 0711015 0711016 0711017 0711018 0711019 0711020 0711022 0711023 0711024 0711025 0711027 0711028 0711029 0711030 0711031 0711032 0711033 0711034 0711035 0711036 0711037 0711038 0711039…
FDA’s list runs to 5,901 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 5,901 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.