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Consumer Reports’ safety experts tell parents to stop using the Otteroo; the company refuses to recall it
The Otteroo “neck float” is an inflatable ring that, its manufacturer says, gently keeps a baby’s head above water in a bath or a pool, so they are free to kick and turn and play. The smaller of the two versions is marketed for babies as young as 2 weeks old, while the larger one targets children up to 35 pounds. The products are described as perfect for bath or pool time, as well as for use in the type of water therapy that special needs babies might benefit from.
But the popular product line—Otteroo says 430,000 of its neck floats have sold since hitting the market about 10 years ago—has been implicated in multiple injuries and at least one infant death. And despite warnings from both the Food and Drug Administration and the Consumer Product Safety Commission that the products are unsafe, they remain for sale.
In a public statement in June 2022 warning against the product’s use, the FDA (which regulates medical devices) said baby neck floats could lead to neck strain or injury, especially in babies with special needs. The agency said some baby neck floats were being marketed “for use as a water therapy tool” without the agency’s approval, though it did not name Otteroo specifically.
Five months later, the Consumer Product Safety Commission added to the pressure and singled Otteroo out directly. In a public statement, the agency said that a 6-month-old infant had drowned in Maine in 2020 after slipping through the neck hole of an Otteroo, according to an incident report, and that a 3-month-old had been seriously injured in New York in 2022 in a similar situation.
In all, the CPSC said it had received 68 incident reports since the Otteroo went on the market that all involved babies having to be rescued by caregivers. (Some of those reports referred to the first iteration of Otteroo that launched in 2014, which the company voluntarily recalled in 2015.) Many of the babies in the agency’s publicly available incident reports recovered immediately and had no lasting injuries; others required hospital visits, CPR, or even intubation, according to the reports.
The agency said Otteroo had not complied with its requests to initiate an acceptable recall of its current products and warned consumers to stop using them.
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 is in the process of finalizing three studies that she says will address the FDA’s concerns about potential neck strain or injury risk from the products. 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.”
“The use of these products can lead to death or serious injury,” says Ashita Kapoor, associate director of product safety at CR. “If you do experience any incident while using this product, please report it to the CPSC.”
Oriene Shin, policy counsel for CR, faults Otteroo for thinking its product warnings will do all the work of keeping babies from getting hurt.
“You cannot rely on warnings,” she says. “Warnings don’t absolve a company of the requirement to create a safe product. These products are not safe, cannot be made safe with warnings, and should not exist. Especially for newborns.”
Otteroo baby neck floats are still for sale through the company’s website. According to a CPSC press release about the previous recall in 2015, Otteroos were once sold through Amazon and Zulily, but they are no longer for sale there. Amazon told CR that “inflatable neck floats for children” is a product category considered hazardous and specifically prohibited from sale. Zulily did not respond to a request for comment.
Since the CPSC’s press release last fall, the agency has received at least six more reports of incidents of babies suddenly slipping through their Otteroos into the water below. Most of these babies were not injured, but one 9-month-old boy who fell into the water in December 2022 required CPR and a hospital stay, according to the incident reports.
The latest incident, reported July 6, involved a 7-week-old boy who, the report says, briefly stopped breathing because a partially deflated Otteroo put pressure on his neck; when his parent removed him from the Otteroo, he started breathing again.
Editor’s Note: This article has been updated to clarify the status of three new studies that Otteroo is conducting. The article had previously stated that the studies had already been provided to the FDA.
Lauren Kirchner is an investigative reporter on the special projects team at Consumer Reports. She has been with CR since 2022, covering product safety. She has previously reported on algorithmic bias, criminal justice, and housing for the Markup and ProPublica, and was a finalist for the Pulitzer Prize in Explanatory Reporting in 2017. Send her tips at email@example.com and follow her on Twitter @lkirchner.
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