Otteroo’s founder, Tiffany Chiu, denies that her products are unsafe and that they need to be recalled.
In response to CR’s questions, Chiu called the death in Maine “heartbreaking,” but said that there were “many murky details” involved, and that it appeared that the baby who drowned had been left alone in a bathtub. Moreover, she said that “a baby slipping into the water isn’t only possible with Otteroo; babies can slip out of bath seats, parents hands, etc., but as long as the parent is with them and attentive, no harm is done.”
She also said that the product’s labeling sufficiently warns parents about the risk, and that in response to the FDA statement in June 2022, the company increased the number of warnings customers see while shopping for or using the Otteroo. Before buying an Otteroo on the company’s website, customers must click “I agree” to show that they understand the product’s hazards, and then later in the process check a box that says “I will be within arm’s reach of my baby in Otteroo at all times.”
Chiu told CR that the company has met multiple times with the FDA in its efforts to register the neck floats as medical devices, and has provided the agency with three studies that she says show that they do not, in fact, pose any neck strain or injury risk. She said the company often hears from pediatric therapists who previously used Otteroos in water therapy sessions and want to know “whether the FDA has come to their senses.”
“We also hear from parents of babies with special needs who tell us how our product is one of the only things to bring joy to their baby because Otteroo time in water is often the only time their children can experience the ability to move freely and experience normalcy,” Chiu said.
The FDA told CR that it stood by its recommendation that consumers not use baby neck floats and that it would update the public if any new information became available. The CPSC said it “maintains that all models of the Otteroo flotation ring pose a significant risk of injury and death, and that parents should immediately stop using them.”