CO2 Incubators (General Purpose Incubator)
Medical device recall Z-1079-2013. Published in FDA’s Enforcement Report on Apr 17, 2013.
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 Apr 17, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 50 states named
- 15,567 incubators 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?
Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. Product Usage: Incubators are designed to maintain an optimal environment for the incubation of tissue and cell samples. These models are designed to maintain temperature, carbon dioxide, and humidity levels.
15,567 incubators, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model 370: Serial #’s: 300028-325 to 30028-326; 300031-327 to 30031-331; 300111-332 to 30011-350; 300112-351 to 300112-365; 300113-366 to 300113-379; 300114-380 to 300114-383; 300208-386 to 300208-390; 300208-392 to 300208-397; 300209-398…
Every code shown here, 1,991 characters
Model 370: Serial #’s: 300028-325 to 30028-326; 300031-327 to 30031-331; 300111-332 to 30011-350; 300112-351 to 300112-365; 300113-366 to 300113-379; 300114-380 to 300114-383; 300208-386 to 300208-390; 300208-392 to 300208-397; 300209-398 to 300209-404; 300209-406 to 300209-411; 300210-412 to 300210-422; 300210-424; 300211-426 to 300211-444; 300285-445 to 300285-458; 300287-459 to 300287-466; 300288-467 to 300288-480; 300382-481 to 300382-494; 300383-495 to 300383-508; 300384-509 to 300384-522; 300385-523 to 300385-526; 300473-527 to 300473-531; 300474-532 to 300474-541; 300475-542 to 300475-551; 300476-552 to 300476-553; 3000551-384 to 300551-385; 300581-554 to 300581-563; 300583-564 to 300583-580; 300584-581 to 300584-600; 300670-601 to 300670-610; 300671-611 to 300671-624; 300672-625 to 300672-638; 300748-639 to 300748-650; 300749-651; 300750-653 to 300750-655; 300751-656 to 300751-659; 300840-660 to 300840-663; 300841-664 to 300841-667; 300842-668 to 300842-677; 300842-679 to 300842-683; 300843-684 to 300843-697; 300925-698 to 300925-707; 300925-709 to 300925-711; 300926-712 to 300926-725; 300927-726 to 300927-739; 300928-740 to 300928-751; 301005-752 to 301005-764; 301006-765 to 301006-781; 301007-782 to 301007-798; 301008-799 to 301008-814; 301080-815 to 301080-827; 301081-828 to 301081-837; 301082-838 to 301082-845; 301083-846 to 301083-857; 301204-858 to 301204-861; 301204-863: 301204-865 to 301204-867; 301204-871; 301205-872 to 301205-873; 301205-875 to 301205-884; 301206-885 to 301206-897; 301306-898 to 301306-907; 301391-908; 301391-911; 301391-914 to 301391-917; 301393-1032 to 301393-1039; 301479-918; 301480-919 to 301480-926; 301481-927 to 301481-932; 301584-933 to 301584-955; 301585-956 to 301585-971; 301586-972 to 301586-983; 301587-984 to 301587-994; 301678-1000 to 301678-1004; 301678-995 to 301678-999; 301679-1005 to 301679-1007; 301680-1008 to 301680-1010; 301771-1011 to 301771-1012; 301772-1013 to 301772-1017; 301773-1018 to 301773-1019;…
FDA’s list runs to 64,705 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.
Worldwide Distribution - USA (nationwide) including the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SN, TN, TX, UT, VA, VT, WA, WI, WV & WY. and the countries: AFGHANISTAN, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, CANADA, CHILE, COSTA RICA, DENMARK, EGYPT, ENGLAND, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, ICELAND, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KOREA, LEBANON, MALAYSIA, MEXICO, NEPAL, NETHERLANDS, NEW ZEALAND, NORWAY, PALESTINE, PEOPLES REPUBLIC OF CHINA, PERU, PHILIPPINES, PORTUGAL, QATAR, REPUBLIC OF PANAMA, ROMANIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, VENEZUELA, VIETNAM & WEST INDIES.
The states and territories these words name
50 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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 Nov 29, 2012.
- FDA classified it on Apr 10, 2013.
- FDA’s Enforcement Report published it on Apr 17, 2013.
- FDA terminated it on Apr 14, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Thermo Fisher Scientific (Asheville) LLC, of Marietta, OH.
- 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 64,705 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
-
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.