CLASS II ONGOING Device recall · Reported 24 Jan 2024 · FDA Enforcement Report

MINC+ Benchtop Incubator, Reference recalled by Cook Medical

Cook Medical is recalling MINC+ Benchtop Incubator, Reference, distributed in California, Louisiana, Maryland, New York. The recall was initiated on 7 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316

Quantity recalled14 US; 101 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0722-2024
FDA event ID: 93673
Recalling firm: Cook Medical, Bloomington, IN
Classification: Class II
Status: Ongoing
Recall initiated: 7 Dec 2023
FDA classified: 12 Jan 2024
Reported: 24 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

7 Dec 2023	Recall initiated by company
12 Jan 2024	Classified by FDA	+36 days
24 Jan 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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

Where it was distributed

Domestic distribution to CA IN LA MD NY International distribution to AUSTRALIA AUSTRIA SPAIN FINLAND FRANCE INDIA IRELAND ITALY KUWAIT SWITZERLAND TURKEY UNITED KINGDOM

California Louisiana Maryland New York

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 00827002444294 Lots AM109365 AM109363 AM109356 AM111934 AM111932 AM111933 AM112041 AM112042 AM112039 AM112040 AM112043 AM112071 AM112072 AM112316

Where was it sold?

Domestic distribution to CA IN LA MD NY International distribution to AUSTRALIA AUSTRIA SPAIN FINLAND FRANCE INDIA IRELAND ITALY KUWAIT SWITZERLAND TURKEY UNITED KINGDOM

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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