Parents warned to stop using infant sleep positioners

FDA and the Consumer Product Safety Commission (CPSC) jointly warned parents against the use of sleep positioners for their babies, because the devices can suffocate infants in their cribs or bassinets.

The agencies reported the deaths of 12 infants aged 1 to 4 months when they suffocated in their sleep positioners or became trapped between a sleep positioner and the sides of their cribs. Most of the infants suffocated when they rolled from a side to a stomach position.

The manufacturers of both flat-mat positioners with side bolsters and inclined wedge mats with side bolsters claim to help infants sleep on their backs and reduce the risk of sudden infant death syndrome (SIDS). FDA says it is unaware of any scientific studies demonstrating that the devices prevent SIDS or other life-threatening harm and has called for the manufacturers to submit clinical data showing that benefits of their products outweigh the risk of suffocation.