CO2 Incubators — Class II medical device recall Z-1079-2013
Terminated recall by Thermo Fisher Scientific (Asheville) LLC, reported 2013-04-17, distributed nationwide. Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
| Recall number | Z-1079-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thermo Fisher Scientific (Asheville) LLC, Marietta, OH, United States |
| Recall initiated | 2012-11-29 |
| Classified | 2013-04-10 |
| Reported by FDA | 2013-04-17 |
| Terminated | 2015-04-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AF, AR, AT, AU, BE, BR, CA, CH, CL, CN, CR, DE, DK, EG, ES, FI, FR, GB, GR, HK, ID, IE, IL, IN, IS, IT, JM, JO, JP, KR, LB, MX, MY, NL, NO, NP, NZ, PA, PE, PH, PT, QA, RO, SE, SG, TH, TN, TR, TW, VE, VN, ZA |
| Quantity | 15,567 incubators |
| Serial numbers | 29175-24, 300002-9, 300003-10, 300015-11, 300015-14, 300028-325, 300031-327, 300032-211, 300032-213, 300035-230, 300035-234, 300036-88, 300037-89, 300038-90, 300039-91, 3000551-384, 300092-15, 300093-16, 300093-18, 300100-61, 300100-70, 300101-80, 300101-82, 300102-45, 300102-46 and 475 more |
| Model numbers | 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, 3599, 370, 371, 380, 381 |
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 for recall
Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1079-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.