Z-1377-2018Class II

MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled...

Name: Z-1377-2018 MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled...
Creator: Cook Inc.
Published: 2018-01-12
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2018-01-12 / Terminated / root cause: design

FDA source

Cook Inc. began a recall of MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell... on 2018-01-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1377-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-12
Posted: 2018-04-13
Terminated: 2020-05-08
Recalling firm: Cook Incorporated
Product: MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000 US) G46022 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
Product code: MQG Accessory, Assisted Reproduction
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.
Root cause tag: design
FDA root cause: Device Design
Action: Cook plans to begin notifying consignees of the recall on January 12, 2018 Written recall communication letters will be mailed via courier to US consignees
Quantity in commerce: 483
Distribution: Nationwide (K-IMNC-100 -US G46022) . (K-IMNC-100 G20079 manufactured in Australia and distributed worldwide)
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1377-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1377-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1378-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17

Product code MQG

K983642Class IICook Mini-IncubatorCook Ob/Gyn / cleared 1999-02-01

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)