The FDA cautions parents and caregivers against purchasing baby products with claims to prevent or reduce the chance of Sudden Infant Death Syndrome (SIDS) (sometimes called Sudden Unexpected Infant Death or SUID). These baby products can pose a risk of serious injury to a baby, including the risk of suffocation.
Common baby products with these claims include:
- Infant sleep positioners - these products should not be used due to the risk of serious harm (see below)
- baby monitors
- crib tents
- crib bedding, including bumpers and blankets
What Should Parents/Caregivers Know About These Baby Products?
- Do not use infant positioners --- they could harm your baby. These free-standing devices are placed in the crib or bassinet and are intended to hold an infant on their side or back while sleeping. The most common types of sleep positioners feature bolsters attached to each side of a thin mat and wedges to elevate the baby’s head.
- The FDA is aware of infant deaths from these products over the years. Infants may suffocate after rolling from a side to stomach position or after being placed on their sides in the positioning product. Even if placed properly on their backs, infants may scoot up or downward on the positioning device, and may become entrapped in the product or between the positioning device and the crib, play yard, sleep mat or bassinet.
- Infant positioning products pose a risk of suffocation, whether or not they make medical claims.
- The FDA is not aware of any clinical or scientific evidence that shows that currently available baby products prevent or reduce the chance of SIDS.
- Be aware that any product that claims to prevent or reduce the chance of SIDS has never been cleared or approved for that use by the FDA.
- The FDA discourages consumers from purchasing any product claiming to reduce a baby’s SIDS risk. These products are not proven to prevent SIDS.
- Always check with your health care professional before using any new medical product for your baby.
Report a Problem
If you experience an injury or malfunction when using an infant sleep positioner, we encourage you to file a voluntary report by phone at 1-800-FDA-1088 or online at MedWatch, the FDA Safety Information and Adverse Event Reporting program.
Please include the following information in your reports:
- Device Name (Brand Name)
- Manufacturer’s Name
- Details of Adverse Event and Medical and/or Surgical Interventions (if applicable)
- About SIDS and SUID | CDC
- American Academy of Pediatrics Updates Safe Sleep Recommendations: Back is Best
- AAP Reduce the Risk of SIDS
- About SIDS and Safe Infant Sleep | NIH
- Ways to Reduce Baby’s Risk | NIH