FDA (Devices) recall action 79711
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.
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.