FDA Device recall Z-1079-2013
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3…
- FDA Device
- Class II
- terminated
- Published 2013-04-17
On 2013-04-17 the FDA classified a Class II recall of CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3… by Thermo Fisher Scientific Asheville, citing incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1079-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-29 |
| Published | 2013-04-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Thermo Fisher Scientific Asheville |
| Distribution | US |
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.
Reason
Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
Identifiers
| code_info | Model 370: Serial #'s: 300028-325 to 30028-326; 300031-327 to 30031-331; 300111-332 to 30011-350; 300112-351 to 300112-…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 30084 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1079-2013%22
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