Class II — Thermo Fisher Scientific (Asheville) LLC
| Recalling firm | THERMO FISHER SCIENTIFIC INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field. |
| Product | 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. |
| Quantity | 15,567 incubators |
| Distribution | 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, EGY… |
| Initiated | 2012-11-29 |
| Classified | 2013-04-10 |
| Terminated | 2015-04-14 |
| Recall number | Z-1079-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Thermo Fisher Scientific (Asheville) LLC (Z-1079-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64418/
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