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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication

The FDA is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy intervention, 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 safety communication provides important information about neck floats, including:

• Details on the potential risk of death or injury in babies
• Recommendations for parents, caregivers, and health care providers
• Instructions for reporting problems with a medical device.

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).