On June 28,2022, the U.S. Food and Drug Administration (FDA) issued a safety communication about using neck float with babies. This occurs when a serious injury has been reported while using a device or product. The FDA warns parents, caregivers, and health care providers not to use neck floats with babies for water therapy interventions, especially with babies who have developmental delays or special needs, such as spinal muscular atrophy (SMA) type 1. The use of neck floats can lead to death or serious injury.

Neck floats are inflatable plastic rings that can be worn around a baby’s neck and allow babies to float freely in water.

FDA recommendations:

  • 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.
  • Be aware that the use of neck floats in babies with special needs can lead to increased risk of neck strain and injury especially when not directly supervised.
  • Be aware that these neck floats have not been evaluated by the FDA

If you are aware of a baby or individual in your care who is injured by a neck float, we encourage you to report this to the FDA. Your report, along with information from other sources, can help the FDA identify and better understand the risks associated with medical devices.

For further information, please go to:

https://www.fda.gov/medical-devices/safety-communications/do-not-use-baby-neck-floats-due-risk-death-or-injury-fda-safety-communication

ACTION: Cure SMA discontinued distribution of neck floats in care packages. We recommend not using neck floats for infants with SMA.

Please contact [email protected] with questions.