The U.S. Food and Drug Administration (FDA) is warning parents and caregivers to avoid using baby neck floats as they could cause serious injury or death.

The FDA said in a release on Tuesday that one baby has died and another is in the hospital in connection to use of the device. In both incidents, the baby was not being "directly monitor[ed]" by their caregivers.

It cautioned against using the popular inflatable rings for water therapy, "especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy."

"The use of these products can lead to death or serious injury," the FDA added, noting that babies with special needs are at a higher risk of suffering neck injuries.

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Using the baby neck floats could also lead to drowning and suffocation, per the FDA.

The neck floats, which hold up the baby's head so they can move around in the water, are typically used during baths, in a swimming pool, and for water therapy. Some companies advertise the device to parents, guardians, and caregivers with babies "as young as two weeks old or premature babies."

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"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 agency warned.

Some advertisers also claim the floats can help a child develop skills like better muscle tone and wider range of motion. However, the FDA said the "safety and effectiveness" have yet to be proven.

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It said that death and injury related to the baby neck floats don't occur often, but it wants to let parents know that both do indeed happen.

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It urges individuals to report injuries related to the baby neck floats immediately.

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