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Today, the U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use infant head shaping pillows intended to change an infant’s head shape and/or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows. These infant head shaping pillows are unapproved medical devices that may create an unsafe sleep environment. The safety communication provides important information about unapproved infant head shaping pillows, including:
- Background on the potential risk of death or injury in infants.
- Recommendations for parents, caregivers, and health care providers.
- FDA actions to increase awareness of this safety concern.
- Instructions for reporting problems to the FDA and the manufacturer.
Questions?
If you have questions about this safety communication, contact the Division of Industry and Consumer Education (DICE).
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