The Consumer Product Safety Commission is warning parents to "immediately" stop using baby neck floats after at least one child drowned and another was seriously injured while using the products.
The warning centers around LUMI and MINI infant flotation rings sold by Otteroo Corporation.
According to the CPSC, the floatation rings can deflate during use or storage, causing the child to slide out of the product into the water, which can lead to serious injury or death.
One infant has died by drowning and one infant was seriously injured after slipping through an Otteroo infant flotation ring, the CPSC said in a statement. The death occurred in 2020 in Maine and involved a six-month old. The serious injury occurred in 2020 in New York and involved a three-month old.
Additionally, the CPSC is aware of 68 incidents where infants slipped through the head opening of the flotation ring and required immediate rescue by a caregiver.
The Otteroo infant flotation rings have been sold nationwide since January 2014 for between $24 to $40. The rings are currently sold exclusively on otteroo.com, and were previously sold on Zulily.com and Amazon.com.
"Otteroo has refused to agree to CPSC's request for an acceptable recall," the agency said.
In response, Otteroo said its neck floats come with thorough safety instructions and warnings which, if followed, will ensure safe use. The company says these warnings make it clear that neck floats are meant to be used under close and constant adult supervision. The company also says it instructs parents to check for air leaks before each use because deflation can pose a drowning hazard if the adult is not within arm's reach of the baby at all times.
Otteroo added that while it is deeply saddened by the two events, it appears that in both incidents the infants were left alone in the bath for an extended period of time. Additionally, the company said there are inconsistencies and limited evidence concerning whether Otteroo neck floats were directly responsible.
The MINI and LUMI are clear, inflatable rings designed to fit around the neck of an infant. "Otteroo" is printed on the top of the rings, which also have an illustrated white otter with an inflatable ring around its neck. Earlier models are inflatable rings bearing the word "Otteroo" and an illustrated white otter, and they are constructed of both clear and blue plastic material.
"CPSC urges consumers not to buy the Otteroo infant flotation rings. If you already own one or purchased one, do not use it due to the drowning hazard and dispose of the product immediately," the agency said. "CPSC urges consumers not to resell or donate the Otteroo infant flotation rings so other infants are not put in danger by the hazard."
The Food and Drug Administration previously cautioned against the use of infant neck floats, especially when worn by babies with developmental disabilities. The rings are often used in water therapy to treat children with spina bifida, spinal muscular atrophy and cerebral palsy.
The FDA says supposed health benefits of the floats -- such as increased muscle tone, greater flexibility and range of motion, increased lung capacity, and better sleep quality -- have not been proven.
"Be aware that these neck floats have not been evaluated by the FDA and we are not aware of any demonstrated benefit with the use of neck floats for water therapy interventions," the FDA said in a statement. "The safety and effectiveness of neck floats to build strength, to promote motor development or as a physical therapy tool, have not been established."
Product-related injury or incidents with the Otteroo infant flotation rings can be reported to the CPSC at SaferProducts.gov.
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