Medical Devices

Tips for Parents / Caregivers

FDA cautions parents and caregivers against purchasing baby products with claims to prevent or reduce the chance of Sudden Infant Death Syndrome (SIDS). Common baby products like pillows, crib bedding and infant positioners can pose a suffocation risk to your baby.

What Should Parents/Caregivers Know?

  • Do not use infant positioners --- they could harm your baby. The FDA is aware of 13 infant deaths in the past 13 years associated with the use of infant sleep positioners.
  • The FDA is not aware of any evidence that shows that baby products prevent or reduce the chance of SIDS.
  • Any product that claims to prevent or reduce the chance of SIDS has never been cleared or approved for that use by the FDA.
  • Do not buy baby products simply because they say they will reduce SIDS risk --- they will not.
  • Always check with your health care professional before using a new product for your baby or other over-the-counter medical products.
  • For tips for online buying of baby products, visit Buying Medicines and Medical Products Online.

Tips for Reducing the Chances of SIDS

The National Institute of Child Health and Human Development recommends that the best way to reduce the chance of SIDS is to create a safe sleep environment for a baby.

A safe sleep environment for a baby is alone in their own sleeping space, with no other people in the crib or bassinet; on their backs on a firm sleep surface; and in a crib or bassinet free of pillows, blankets, bumpers, sleep positioners, and other objects.

Page Last Updated: 06/04/2014
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