The Recall Desk
HighFDA (Devices)·Z-1079-2013·Announced 2013-04-17

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.

What this means for you

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. T
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

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Same manufacturer · Thermo Fisher Scientific (Asheville) LLC

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