Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 17, 2013
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.
Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
Thermo Fisher Scientific (Asheville) LLC recalled CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308,… - a moderate-severity action.
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308,… was recalled by Thermo Fisher Scientific (Asheville) LLC in April 17, 2013. Reason: Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.. Check the official notice for the remedy. Verify recall #Z-1079-2013 with the FDA Devices before acting.
The recall
Thermo Fisher Scientific (Asheville) LLC issued this moderate-severity FDA Devices recall-Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field..
- Moderate
- severity level
- Class II
- classification
- April 17, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1079-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1079-2013) was formally reported on April 17, 2013, with the manufacturer initiating the action on November 29, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Thermo Fisher Scientific (Asheville) LLC is listed as the recalling firm, operating out of Marietta, OH. Federal records list the affected scope as 15,567 incubators.
The documented reason for this recall is: Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field. Distribution data in the federal record shows the product reached: 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, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15,567 incubators
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1079-2013 |
| Date reported | April 17, 2013 |
| Date initiated | November 29, 2012 |
| Recalling firm | Thermo Fisher Scientific (Asheville) LLC |
| Firm location | Marietta, OH |
| Affected scope | 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, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1079-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was 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.. Recalled by Thermo Fisher Scientific (Asheville) LLC. Units affected: 15,567 incubators.
Why was this product recalled? ▼
Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 17, 2013. Severity: Moderate. Recall number: Z-1079-2013.
Where was the recalled product distributed? ▼
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, 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1079-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 17, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.