Cook recallZ-0722-2024 · Cook Medical Llc · initiated Dec 7, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook Medical Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0722-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 7, 2023
- Posted by the FDA
- Jan 12, 2024
- Recalling firm
- Cook Medical Llc
- Quantity
- 14 US; 101 OUS
- Product code
- MQG
- Distribution
- Domestic distribution to CA IN LA MD NY International distribution to AUSTRALIA AUSTRIA SPAIN FINLAND FRANCE INDIA IRELAND ITALY KUWAIT SWITZERLAND TURKEY UNITED KINGDOM
Product description
MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Code information (models, lots, serial numbers)
UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- COOK G44429William A. Cook Australia Pty. Ltd. · Accessory, assisted reproduction1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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