Toymaker Fisher-Price has recalled nearly five million of its Rock 'n Play Sleepers after reports linked the product to dozens of baby deaths, reports BBC.
The recall was announced by the US Consumer Product Safety Commission (CPSC) on Friday (Apr 12).
On its website, the commission said at least 30 infants had died in the sleeper model since its 2009 release.
In a statement, Fisher-Price owner Mattel confirmed the voluntary recall but stood by the product's safety.
The CPSC said that it was aware of 10 infant deaths in the Rock 'n Play that occurred when infants rolled from their back onto their stomach or side while unrestrained.
All of the 10 infants were at least three months old.
Fisher-Price had warned customers to stop using the sleeper once infants can roll over.
"While we continue to stand by the safety of all of our products, given the reported incidents in which the product was used contrary to safety warnings and instructions, we've decided in partnership with the Consumer Product Safety Commission (CPSC), that this voluntary recall is the best course of action," Fisher-Price said.
The CPSC has estimated the recall affects about 4.7m products.
It has urged consumers to stop using the sleepers immediately and contact Fisher-Price for a refund.
Earlier this week, the American Academy of Paediatrics (AAP) urged the product's recall, labelling the sleeper "deadly".
"When parents purchase a product for their baby or child, many assume that if it's being sold in a store, it must be safe to use. Tragically, that is not the case," the president of the AAP, Kyle Yasuda, said in a statement.
The AAP cited a report by US magazine website Consumer Reports, which linked the product to 32 separate infant deaths.