PROVIDENCE, R.I. (WPRI) — The U.S. Food and Drug Administration (FDA) is urging parents and caregivers to not put neck floats on their babies after one infant died and another was hospitalized.

The FDA said the inflatable rings “are designed to cradle a baby’s head while their body moves freely in water.”

“Parents and caregivers have used these products during a baby’s bath, while their baby is swimming and as a physical therapy tool (water therapy intervention) for babies with developmental delays or disabilities,” the FDA said.

The FDA warned that use of the neck floats “can lead to death or serious injury.” The neck floats, according to the FDA, can cause a baby to drown, suffocate, strain their muscles or suffer a serious neck injury.

The neck floats can be especially dangerous for babies with developmental delays or special needs, which the FDA said some manufacturers are marketing them for.

“The FDA is aware that some manufacturers are claiming these products support water therapy interventions in babies with developmental delays or special needs and that the benefits of these products include increased muscle tone, greater flexibility and range of motion, increased lung capacity, better sleep quality, and increased brain and nervous system stimulation,” the FDA said. “The safety and effectiveness of neck floats to build strength, to promote motor development or as a physical therapy tool, have not been established.”

There have been two reports of the neck floats causing serious injury, which include one death and one hospitalization. In both instances, the FDA said the caregivers did not directly monitor the children after placing them in the neck floats.

The FDA believes that, while death or serious injury from neck floats is rare, parents and caregivers should be aware of the possibility.

Parents and caregivers are urged to report any injuries or “adverse events” involving the neck floats to the FDA through its MedWatch reporting program.