CooperSurgical, Inc. has recalled approximately 994 units of global Medium (models LGGG-020, LGGG-050, and LGGG-100) after discovering performance issues that can impair or stop human embryo development. These products are used in specialized laboratories for the culture of human embryos from the zygote stage to the blastocyst stage and for embryo transfers. The recall was prompted by a sudden increase in complaints specifically associated with three production lots, where embryos failed to develop as expected. Consumers and clinics should immediately stop using the affected lots and contact the manufacturer for replacement or further instructions.
The defective culture medium can fail to support normal growth, leading to impaired or halted development of human embryos before they reach the critical blastocyst stage. This can result in the loss of viable embryos for patients undergoing fertility treatments like IVF.
Manufacturer replacement and clinical consultation.
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.