The Recall Desk
HighFDA (Devices)·Z-1377-2018·Announced 2018-04-25

Cook Inc. Recalls MINC Benchtop Incubators Due to Temperature Control Defect

Cook Inc. is recalling 483 MINC Benchtop Incubators because a heater failure may cause temperatures to become too high or too low for proper cell culture.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm to the product's intended use (cell culture) due to temperature control failure, but no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Cook Inc. is recalling 483 units of the MINC Benchtop Incubator (Mini Incubator), catalog K-MINC-1000 US, G46022. These microprocessor-controlled, gassed, and humidified incubators are intended for use in cell culture. The recall covers all lots of the product.

The recall was initiated because the temperature of the incubation lids may become too high or too low for proper gamete or embryo incubation. This issue is caused by fatigue failure of the flat flex lid heater. The affected units were distributed nationwide and worldwide.

Consumers and facilities using these incubators should stop using the product and contact Cook Inc. for further instructions on repair or replacement.

The recalled product

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.
Manufacturer
Cook Inc.
Affected units
483

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →