CooperSurgical, Inc. has recalled approximately 277 K-Systems incubators and warming plates because the well or surface temperatures can exceed the desired set temperature. The recall affects G73 and G85 incubators, T47 warming plates, and R65 trolleys. While these devices are designed to sound an alarm if temperatures exceed the safe range, there is a risk that excessive heat could damage sensitive biological materials like gametes or embryos used in fertility procedures. No injuries or incidents have been reported at this time.
The warming surfaces or incubator wells may reach temperatures higher than what the user has set. This overheating can damage or destroy reproductive materials such as embryos and eggs, potentially causing the failure of assisted reproduction procedures.
An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials.
Units distributed in India and Australia as lab equipment. Identifiers are one of the five noted affected part numbers above.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.