Parents are being urged to stop using infant crib positioners due to suffocation risk.
The federal government is urging parents to stop using "crib positioners" designed to protect babies from Sudden Infant Death Syndrome, or SIDS.
Doctors say babies should sleep on their back, which is what infant sleep positioners cushions claim to help do.
SIDS expert Dr. Henry Krous says those devices do not actually keep a baby safer while sleeping.
"To the contrary, they look like something that the baby could roll over and then the baby could get itself in a dangerous position," he explains.
That's exactly what the warning from the FDA and Consumer Product Safety Commission tells parents.
It was issued in the wake of the deaths of a dozen infants over a 13 year span, and many more complaints.
The warning says: "Using a positioner to hold an infant on his or her back or side for sleep is dangerous and unnecessary" and "To date, there is no scientifically sound evidence that infant sleep positioners prevent SIDS."
"It's a pity that they don't get tested in some real way. And I am sure these are not the last ones. I can't imagine that new ones won't be designed and put on the market in the future," says Dr. Krous.
He says babies should sleep on their back, on a firm surface without any overstuffed materials.
The best advice, he says, is the easiest to follow.
"The simple thing is don't use the devices at all. That's the safest thing. It's the cheapest thing, and it's the most effective thing."
There's no recall now, but FDA officials say we should expect one in the future.