Z-0722-2024Class II

MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429

Name: Z-0722-2024 MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Creator: Cook Medical Llc
Published: 2023-12-07
License: https://open.fda.gov/license/

Cook Medical LLC / initiated 2023-12-07 / Open, Classified / root cause: design

FDA source

Cook Medical Llc began a recall of MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429 on 2023-12-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0722-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-07
Posted: 2024-01-12
Recalling firm: Cook Medical LLC
Product: MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
Product code: MQG Accessory, Assisted Reproduction
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 14 US; 101 OUS
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 codes and lots: UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0722-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0722-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12

Product code MQG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)