The U.S. Food and Drug Administration is warning parents and caregivers to not use infant head shaping pillows.
The head shaping pillows have been unapproved as medical devices by the FDA as they have been found to be unsafe for sleeping environments.
According to the FDA, these products have not been established for the treatment of flat head syndrome. Along with not being fit for treatment, it is warned that these pillows have a risk of sudden unexpected infant death, inclusive of sudden infant death syndrome (SIDS) and suffocation and death.
Infant head shaping pillows are small pillows with a hole or indent that is designed to cradle an infant’s head when they are laying face up. Any caregiver with an infant head shaping pillow is recommended to throw it away and report it to the FDA.