CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report
MINC Benchtop Incubator (Mini Incubator) recalled by Cook
Cook is recalling MINC Benchtop Incubator (Mini Incubator), distributed nationwide in the US. The recall was initiated on 12 Jan 2018 and the FDA has classified it as Class II.
Check your package
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-1378-2018
- FDA event ID
- 79711
- Recalling firm
- Cook, Bloomington, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jan 2018
- FDA classified
- 17 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Other Medical Devices
Timeline
| 12 Jan 2018 | Recall initiated by company | |
| 17 Apr 2018 | Classified by FDA | +95 days |
| 25 Apr 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
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 (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
Where it was distributed
Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
Questions about this recall
Is MINC Benchtop Incubator (Mini Incubator) recalled?
Yes. Cook recalled MINC Benchtop Incubator (Mini Incubator) on 12 Jan 2018. The recall is Class II and its status is Terminated. Recall number Z-1378-2018.
Why was it recalled?
The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater.
Which lots are affected?
All Lots
Where was it sold?
Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
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 21 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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