Fisher-Price has all of its Rock 'n Play sleepers - some 4.7million - after it was revealed 30 babies had died in them in just ten years.
Parents have been urged to stop using the infant sleeper immediately and contact the company for a refund.
The warning was issued by the U.S. Consumer Product Safety Commission (CPSC) which said that 30 children have died in the sleepers since 2009.
It said that the deaths had occurred after the children tolled from their backs onto their stomachs or sides while unrestrained.
However, it did not specify the exact cause of the children's deaths.
A recall notice said: "Since the 2009 product introduction, over 30 infant fatalities have occurred in Rock ‘n Play Sleepers, after the infants rolled over while unrestrained, or under other circumstances."
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The sleepers, which were sold nearly five million times, retailed between $40 and $149 (£30 and £113).
The recall comes after the CPSC warned people not to use the sleepers for infants older than three months since they were likely to roll over.
Chuck Scothon, general manager at Fisher-Price, told CNN the company said recall was the "best course of action" and it will continue to stand by the safety of all its products.
"With these actions, we want parents around the world to know that safety will always be a cornerstone of our mission, that we are committed to these values, and will continue to prioritise the health, safety and well-being of the infants and preschoolers who utilise our products," he added.
It is unclear if the sleepers were sold outside the US.
