The federal Consumer Product Safety Commission and Fisher-Price are recalling all of the company's Rock 'n Play Sleepers, with the commission linking the product to over 30 infant deaths in 10 years.
The recall will impact about 4.7 million sleepers, the commission said.
"I'm urging parents to stop using this product immediately and to contact Fisher-Price for a refund or a voucher," said Ann Marie Buerkle, the CPSC's acting chairwoman.
Chuck Scothon, general manager at Fisher-Price, said the company considered the recall the "best course of action" and 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 prioritize the health, safety and well-being of the infants and preschoolers who utilize our products," Scothon said.
The decision comes a week after the commission and Fisher-Price issued a warning about the product, prompting calls from the American Academy of Pediatrics and grieving parents for an immediate recall.
The commission said Friday that "over 30 infant fatalities have occurred in Rock 'n Play Sleepers, after the infants rolled over while unrestrained, or under other circumstances" since 2009.
The recall did not say what caused the infants' deaths.
Last week, the CPSC had only cited reports of 10 fatalities -- of babies 3 months or older -- but a Consumer Reports analysis linked the popular sleeper to 32 infant deaths, between 2011 and 2018.
Patty Davis, a spokeswoman with CPSC, had said the commission was aware of the report of additional fatalities and were looking into those deaths.
Following Friday's recall, Buerkle said the investigation into the sleepers had been a top priority for the commission and announced that officials will continue looking into other inclined sleep products.
"I urge consumers to report any incidents with inclined sleepers or other nursery products to CPSC at saferproducts.gov," she said in a video statement. "As a mother and grandmother there's nothing more important to me than the safety of our children."
For more information about the recall, customers can contact Fisher-Price at www.service.mattel.com and click on "Recalls & Safety Alerts" or at 866-812-6518 from 9 a.m. to 6 p.m. ET Monday through Friday.
Their 5-month-old son died in 2017
Keenan and Evan Overton's son had been sleeping in the product when he died three days before Christmas 2017.
Their son, 5-month-old Ezra, was napping in the sleeper while his father, Keenan Overton, was asleep on the couch next to him.
"I looked up and I found him in a standing position but faced down in the chair, his face was on the back of the seat and he was already passed away. I picked him up and his face was already blue and his nose was squished in," Keenan Overton told CNN.
Ezra wouldn't have been able to roll over yet, Overton said.
Evan Overton, the infant's mother, said they haven't filed suit but are negotiating with Fisher-Price.
"Fisher-Price and Mattel, their parent company, we are in negotiations to discuss kind of what we expect from talking about and speaking out on the dangers of this chair," Evan Overton said. "Our main thing is to inform other people so, that it won't happen to somebody else."
Jan Hinson, an attorney representing the Overtons, said they were glad to hear about the recall and are now planning to sue Fisher-Price.
"They want parents to know this chair is not for any babies," Hinson said. "The chair is not fit for any age."