FDA CooperSurgical IVF Recall Information for Rochester Residents

FDA CooperSurgical IVF Recall Information for Rochester Residents

In February of 2024, an FDA recall was issued for IVF culture media made by the global fertility supplier CooperSurgical. The CooperSurgical IVF recall addressed problems with several batches of the company's embryo solution that were possibly used in fertility clinics in Rochester and throughout the United States and Canada. This defective medical product resulted in the stagnation and failure of otherwise healthy embryos. Individuals and couples in Rochester who suffered embryo loss as a result of the CooperSurgical IVF recall are now filing claims against the company for damages. This page contains detailed information on the contents of the FDA CooperSurgical IVF recall for Rochester residents and the defect that led to it.

CooperSurgical IVF Embryo Solution in Rochester Clinics

The product in question is known as IVF culture media or embryo solution, and is used by fertility clinics in Rochester. It is manufactured by Connecticut-based CooperSurgical. This is a highly specialized formulation that is designed to create an environment for the growth and development of human embryos in a lab setting, such as fertility clinics in Rochester. Designed to mimic the natural environment of the human uterus, embryo solution is characterized by a specific pH and careful formulation of nutrients.

IVF culture media is used in Rochester clinics in the middle, and arguably most important, step of the assisted fertility process known as in vitro fertilization, or IVF. First, the release of mature eggs must be stimulated using hormones. Then eggs are harvested from the ovaries. The eggs are then combined with sperm in a Rochester lab, and monitored for healthy development from the zygote (fertilized egg) stage to the blastocyst stage, where the embryo is forming inside an outer protective casing. It is during this fertilization and initial development stage that IVF culture medium is utilized by Rochester fertility clinics, as the substance in which the whole process takes place. Once the egg is fertilized and beginning to develop, it can be implanted into the uterus.

Rochester Residents: IVF Culture Media Defects Spur 2023 CooperSurgical Recall

In November and December of 2023, CooperSurgical received a number of reports from embryologists in places like Rochester who were alarmed to see embryos routinely failing to develop from zygotes to blastocysts. Over the course of several weeks, these reports continued to reach desks at CooperSurgical, until December 15, 2023, when the company contacted its clients–such as fertility clinics in Rochester and countless others around the world–to alert them of a problem with several lots of its embryo solution. Fertility clinics such as those in Rochester were asked to stop using these particular batches and return them to the company for a refund. The CooperSurgical culture media recall did not include any information on alerting patients affected by the defective medical product, nor did the company issue any public statement on the recall, which is why fertility patients in Rochester did not learn of the problem until later.

FDA CooperSurgical IVF Embryo Solution Recall Info for Rochester

Two months later, the FDA issued a IVF culture media recall for three lots of CooperSurgical's product. By this time, countless individuals and couples in Rochester and around the U.S. had individually learned of their embryos' failure to develop, yet were mostly unaware of the cause. The FDA embryo solution recall made CooperSurgical's missteps public, and numerous news sources helped to spread the word. People who had lost embryos in Rochester were rightly outraged at both the blatant mistake on the part of CooperSurgical to manufacture the product to specification, but also the company's focus on damage control rather than communication withRochester consumers.

The CooperSurgical FDA embryo solution recall is a global "Class 2" device recall. The reason for the recall is listed as, "The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage." The particular products included in the FDA CooperSurgical recall include: global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). The affected lots are LGGG-020: UDI-DI 00815965020044, lot 231020-018741 LGGG-050: UDI-DI 00815965020051, lot 231020-018742 LGGG-100: UDI-DI 00815965020068, lot 231020-018743. Fertility clinics in thirty-three U.S. states and Canada received the defective IVF culture medium, including AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MO, NV, NJ, NM, NY, NC, OH, OK, OR, PA, RI, TN, TX, UT, VT, VA, WA, WV.

This is not CooperSurgical's first FDA recall for embryo solution. In 2023, an FDA recall was issued for one lot of CooperSurgical IVF culture medium, stating the contents of the containers were not consistent with the labels. This recall affected fertility clinics in New York and Utah, as well as numerous countries around the world including Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, and the United Kingdom.

Rochester CooperSurgical Embryo Solution Lawsuits

Individuals and couples who lost embryos in connection with the CooperSurgical IVF solution recall in Rochester were devastated to learn their loss came from a preventable mistake. What makes matters worse is that CooperSurgical positions itself as an empathetic company working on behalf people in Rochester and beyond facing infertility challenges, yet focused more on corporate damage control than communication with people affected by its mistake. Individuals and couples who lost one or more embryos in Rochester are now filing claims against CooperSurgical to recover compensation for damages. For some harmed by the CooperSurgical IVF recall in Rochester, the promise of holding CooperSurgical accountable matters more than the potential for compensation.

Let Our CooperSurgical IVF Recall Lawyers Serving Rochester Help You

Our attorneys specialize in pursuing justice on behalf of our clients against large institutions, no matter how complex the case. Through settlements and winning verdicts, our attorneys have obtained millions for our clients. Let us help you today.

Embryo Loss Lawsuits for Rochester Residents

Filing a lawsuit will allow you to hold CooperSurgical accountable for the loss of your embryos, while also providing real compensation for the emotional anguish and costs associated with your loss. Contact us today for a free consultation.