Thermo Fisher CO2 Incubators Recalled for Hinge Failure
Thermo Fisher Scientific is recalling 15,567 CO2 incubators manufactured before mid-2009 because their coated metal hinges have reportedly failed in the field.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source notes that the hinges have 'reportedly failed in the field,' indicating a risk of harm or product malfunction without explicit reports of injury or death.
Plain-English summary
Thermo Fisher Scientific (Asheville) LLC is recalling 15,567 CO2 Incubators (General Purpose Incubator) under FDA recall number Z-1079-2013. The affected models are 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599. These incubators are designed to maintain optimal temperature, carbon dioxide, and humidity levels for the incubation of tissue and cell samples.
The recall is due to a defect in the coated metal hinges, which have reportedly failed in the field. The source text specifies that the affected units were manufactured prior to mid-2009. The agency has classified this recall as Class II.
The affected incubators were distributed worldwide, including nationwide in the United States and in numerous international countries. Users should check their incubator model and serial number against the recall list to determine if their unit is affected.
The recalled product
- 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.…
- Manufacturer
- Thermo Fisher Scientific (Asheville) LLC
- Hazard
- Affected units
- 15,567
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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