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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Cook Medical Llc: MINC+ Benchtop Incubators Recalled for Potential Temperature Control Loss

Agency Publication Date: January 12, 2024
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Summary

Cook Medical Llc has recalled 14 units in the U.S. and 101 units internationally of the MINC+ Benchtop Incubator (Reference Part Number K-MINC-2000). The device is susceptible to losing its temperature control if static electricity is applied to the lid. This malfunction can cause embryo degeneration, which may require the patient to undergo additional medical procedures. Consumers should contact Cook Medical or their healthcare provider for further instructions regarding this equipment.

Risk

Static electricity applied to the incubator lid can disrupt the device's temperature regulation. This loss of heat control can damage or destroy developing embryos, leading to failed medical cycles and the need for patients to repeat invasive procedures.

What You Should Do

  1. Identify your device by checking the label for MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, and Order Number (GPN) G44429.
  2. Check the specific lot numbers to see if your unit is affected: AM109365, AM109363, AM109356, AM111934, AM111932, AM111933, AM112041, AM112042, AM112039, AM112040, AM112043, AM112071, AM112072, and AM112316.
  3. Verify the UDI-DI number 00827002444294 located on the product packaging or device label.
  4. Contact Cook Medical Llc at their Bloomington, Indiana headquarters or your local sales representative to discuss the corrective actions outlined in the firm's notification letter.
  5. Contact your healthcare provider or clinic administrator to determine if your specific medical procedures are impacted by this recall.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: MINC+ Benchtop Incubator
Model / REF:
K-MINC-2000
G44429
Z-0722-2024
UPC Codes:
00827002444294
Lot Numbers:
AM109365
AM109363
AM109356
AM111934
AM111932
AM111933
AM112041
AM112042
AM112039
AM112040
AM112043
AM112071
AM112072
AM112316

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93673
Status: Active
Manufacturer: Cook Medical Llc
Sold By: Cook Medical Llc
Manufactured In: United States
Units Affected: 14 US; 101 OUS
Distributed To: California, Indiana, Louisiana, Maryland, New York

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.