The Recall Desk
HighFDA (Devices)·Z-1378-2018·Announced 2018-04-25

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

Cook Inc. is recalling 4,451 MINC Benchtop Incubators because a heater defect 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 intended biological materials (gametes/embryos) due to temperature failure, but no specific human injuries or illnesses are reported in the source text.

Plain-English summary

Cook Inc. is recalling 4,451 units of the MINC Benchtop Incubator (catalog K-MINC-1000, G20079). The recall affects all lots of the device, which is a microprocessor-controlled, gassed, and humidified incubator intended for use in cell culture.

The recall is being conducted because the temperature of the incubation lids may become too high or too low for proper gamete and embryo incubation. This issue is caused by fatigue failure of the flat flex lid heater.

The affected units were distributed nationwide in the United States and worldwide. The source text does not specify specific actions for consumers or users, but the defect poses a risk to the viability of the biological materials being incubated.

The recalled product

Product
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
Manufacturer
Cook Inc.
Affected units
4,451

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 →