MINC+ Benchtop Incubator Recalled for Temperature Control Loss Risk
Cook Medical is recalling MINC+ Benchtop Incubators that may lose temperature control when exposed to static electricity on the lid, potentially causing embryo damage that could require additional medical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a risk-of-harm medical device where temperature control loss could cause embryo degeneration requiring additional medical procedures. However, the source text explicitly states the device "may lead to" this outcome—indicating no illnesses or injuries have been reported. Per the rubric, theoretical hazards with no reported incidents score at most 3.
Plain-English summary
Cook Medical is recalling the MINC+ Benchtop Incubator (Reference Part Number K-MINC-2000). The device is used in fertility clinics and medical facilities for embryo culture and incubation.
The MINC+ is susceptible to losing temperature control if static electricity is applied to the lid of the device. This loss of temperature control may lead to embryo degeneration, which could necessitate additional medical procedures for affected patients.
The recall affects 14 units distributed domestically in California, Indiana, Louisiana, Maryland, and New York, and 101 units distributed internationally to Australia, Austria, Spain, Finland, France, India, Ireland, Italy, Kuwait, Switzerland, Turkey, and the United Kingdom. The affected lot numbers are AM109365, AM109363, AM109356, AM111934, AM111932, AM111933, AM112041, AM112042, AM112039, AM112040, AM112043, AM112071, AM112072, and AM112316.
The recalled product
- Product
- MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429
- Manufacturer
- Cook Medical Llc
Distribution
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