Cook Medical Llc MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Brand
Cook Medical Llc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316
Cook Medical Llc is recalling MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429 due to The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. Thi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional medical procedure for the patient.
Recommended Action
Per FDA guidance
The firm notified affected customers on December 7, 2023 via URGENT Medical Device Correction letters. Per the letter, customers can continue to use their MINC+ device whilst awaiting the defect correction, but Cook advises customers to be vigilant and monitor for device alerts. If the device produces audible and visual alerts to indicate an error with temperature, customers must immediately move any dishes to another incubator. If no other incubators are available, the device can be reset to normal operation by switching off mains power to the device for ten seconds then turning the power back on. The software/firmware update will undergo verification testing including compliance testing prior to release. The updated software/firmware is expected to be available on 01 February 2024. An authorized service agent will contact customers to arrange for the device to be corrected at their facility. The service agent will be updating the software/firmware of the device.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IN, LA, MD, NY
Page updated: Jan 10, 2026