Quantum 2000 Electrosurgical Generators Cooper Surgical
Medical device recall Z-0263-2022. 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
- 154 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?
XXX
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075-05W
154 Units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 0111001 0111003 0111004 0111005 0111006 0112001 0112002 0112003 0113001B 0113002B 0113003B 0113004B 0113005B 0113006B 0113007B 0113008B 0113010B 0114001 0114002 0114003 0114004 0114005 0114006 0114007 0114008 0114009…
Every code shown here, 1,393 characters
Serial Numbers: 0111001 0111003 0111004 0111005 0111006 0112001 0112002 0112003 0113001B 0113002B 0113003B 0113004B 0113005B 0113006B 0113007B 0113008B 0113010B 0114001 0114002 0114003 0114004 0114005 0114006 0114007 0114008 0114009 0114010 0209015 0215001 0215002 0215003 0215004 0215005 0215006 0215007 0215008 0215009 0215010 0215011 0312001 0312002 0312009 0312009FIX 0312010 0312028 0413001B 0414001 0414003 0414004 0414008 0414014 0414018 0512001B 0512002B 0513001B 0513002B 0513003B 0514005 0612023B 0612024B 0612025B 0612026B 0612027B 0612028B 0712001B 0712002B 0712003B 0712004B 0712005B 0712006B 0713001C 0713002C 0713003C 0713004C 0713005C 0713006C 0809001SYC 0813020C 0813021C 0813022C 0813023C 0813024C 0813025C 0814010 1012001B 1012002B 1012003B 1012004B 1012005B 1012006B 1012007B 1012008B 1012009B 1012010B 1109018 1109019 1113001C 1113002C 1113003C 1113004C 1113005C 1113006C 1113007C 1113008C 1113009C 1113010C 1213001 1213002 1213003 1214007 2015040001 2015040002 2015040003 2015040004 2015040005 2015050001 2015050002 2015060001 2015060002 2015060003 2015060004 2015060005 2015070004 2015090002 2015090003 2016050001 2016050005 2016070001 2016070002 2016070003 2016070004 2016070005 2016100001 2016100002 2016100003 2016100004 2016100005 2016100006 2016120002 2016120003 2016120004 2016120005 2016120006 2016120007 2016120008 2017060003 2017060005 QTM-AB-1-002 QTMAB-12-175
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.”
- 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.