The United States Consumer Product Safety Commission (CPSC) said more than 30 babies had died in the sleepers since they were first sold in 2009, with 10 deaths caused by the babies rolling over from their backs to their stomachs unrestrained. All 10 babies were 3 months or older.
The recall of the 4.7 million sleepers will affect the UK because they are available to buy online from the US.
The CPSC said people should immediately stop using the sleeper and contact Fisher-Price for a refund.
Chuck Scothon, General Manager at Fisher-Price, confirmed the sleeper had been recalled but said the company stands by the safety of its products and that the sleeper had been used "contrary to the safety warnings and instructions".
Earlier this month Fisher-Price warned consumers to stop using the sleeper once their babies start to roll over, typically around three months old.
The sleeper is manufactured in China and retails at around £80.
Earlier this week the American Academy of Pediatrics urged for the sleeper to be recalled, warning it is "deadly" and that the earlier warning from the CPSC and Fisher-Price had not gone far enough.
Chuck Scothon, General Manager at Fisher-Price, said: "A child fatality is an unimaginable tragedy.
"For almost 90 years, Fisher-Price has made the safety of our children our highest priority.
"In recent days, questions have been raised about the Fisher-Price Rock'n'Play Sleeper. We stand by the safety of our products. However, due to reported incidents in which the product was used contrary to the safety warnings and instructions, we have decided to conduct a voluntary recall of the Rock'n'Play Sleeper in partnership with the Consumer Product Safety Commission.
"Fisher-Price has a long, proud tradition of prioritizing safety as our mission. We at Fisher-Price wants parents around the world to know that we have every intention of continuing that tradition."
Reader Comments
to our Newsletter