The U.S. Food and Drug Administration (FDA) has released a safety warning for parents, caregivers, and healthcare professionals regarding the use of neck floats for infants. The June 28 announcement details how this aquatic therapeutic tool and safety device may result in serious injury or death to infants.

Neck floats consist of an inflatable plastic ring that is placed around the infant’s neck. The intent of these devices is to allow infants to float freely while keeping their heads above water. These devices are advertised for babies who are premature or up to two weeks in age. These rings are used in baths, for recreational swimming, and for use in a form of physical therapy known as water therapy intervention.

Water therapy intervention is used to help children with developmental disabilities such as spina bifida, spinal muscular atrophy type 1, down syndrome, or cerebral palsy. The intent of this therapy is to allow the body of the infant to move freely in the water to build up muscle tone. The benefits of using a neck float in this therapy are advertised as increasing muscle development, flexibility, range of motion, lung capacity, better sleep, and increased nervous system stimulation. The FDA notes that the safety and effectiveness of neck floats as a therapy tool have never been established by the agency.

Instead, the agency concludes in its safety announcement that neck floats put the baby at risk of drowning, suffocating, and straining or injuring the neck. This risk is especially prevalent in babies with spina bifida or spinal muscular atrophy type 1. The FDA has confirmed one infant death and one infant hospitalization after using baby neck floats. In both instances, the infants were not being directly watched by their caregivers.

While deaths or serious injuries are not common according to the FDA, the agency felt it necessary to alert parents, caregivers, and healthcare providers about the occurrence of these serious side effects. The agency explicitly discouraged the use of neck floats, stating, “Do not use baby neck floats for water therapy intervention. The use of these products, especially with babies with developmental delays or special needs, can lead to death or serious injury.”

The agency also noted that neck floats have not been evaluated by the FDA as a medical device and it is unaware of any benefit offered from their use of them in water therapy intervention.