Is the baby product recall process failing parents? Some experts say yes
The reannouncement of a Fisher-Price recall put a spotlight on the process.
Erika Richter said she was first upset and then angry when she saw that nearly five years after her newborn daughter's death, a repeat announcement was made warning parents and caregivers to not use any models of Fisher-Price's Rock 'n Play sleeper.
The sleepers were first recalled in 2019 after 32 infant deaths were linked to them, according to the U.S. Consumer Product Safety Commission. The recall was issued due to the risk of infants rolling from their back to their stomach or their side while in it, the CPSC said.
That recall was too late for Richter, whose 2-week-old daughter Emma died in 2018 due to asphyxia, or the inability to breathe, while sleeping in a Fisher-Price Rock 'n Play Sleeper, according to Richter's attorney, Salvatore Zambri, who is representing her in ongoing litigation against Fisher-Price. In court papers, Fisher-Price has denied wrongdoing.
In its new announcement in January, the CPSC said at least eight additional infant deaths have been associated with the product since the original 2019 recall, when 32 infant deaths were linked to the sleeper.
"I'm heartbroken and I'm devastated that more families are suffering," Richter told "Good Morning America." "When I hear about more families who have lost their little ones, my heart breaks because I know exactly what that feels like, and it shouldn't have to be this way."
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In all, around 100 infants have died while using the Rock 'n Play sleeper, according to the CPSC. In both the recall and the reannouncement, Fisher-Price said that in some reports, it has been unable to confirm the circumstances of the incident or that it involved their product.
Why baby products are so hard to remove from use
Since her daughter's death, Richter, who lives in Portland, Oregon, has become a vocal advocate for the need to reform how baby products are recalled, noting that once a product is on the market, "it's hard to put the horse back in the barn."
"Every parent wants their baby to be safe, but once the market is flooded with an unsafe product, it's hard to bring it back. They're in thrift stores. They're in daycares. They're being handed down from sister to brother. They're everywhere," Richter said. "The impetus should not be on brand-new parents. The impetus should be on the company to make sure that the product is safe in the first place."
Last year, the United States had the highest number of children's product recalls -- impacting everything from baby products to kids' clothes and toys -- since 2013, according to a report released this month by Kids in Danger, a nonprofit organization focused on children's product safety.
Nursery products, items like strollers and baby swings, accounted for over half of the more than 5 million units of children's products recalled in 2022 alone, the report found.
The recall of the Fisher-Price Rock 'n Play sleeper is a textbook example of how challenging it is to recall a baby product once it hits the market, according to Nancy Cowles, executive director of Kids in Danger.
Cowles, citing research done by Kids in Danger, said most parents report hearing about recalls of children's products once or twice a month, when in reality, those recalls happen once or twice per week.
"For most products, we see a range of 10% to 30% effectiveness rate, which means most recalled products are still out there, somewhere," Cowles said. "That leads to mixed messages, because obviously someone is making it, other people are using it, so [parents] assume it must be safe."
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When the Rock 'n Play sleeper was first recalled in 2019, after a decade on the market, there were already nearly 5 million units of the product, according to the CPSC.
The Rock 'n Play sleeper recall advised parents and caregivers to stop using the product and to contact Fisher-Price on their own for a "refund or voucher." At a Congressional hearing in 2021, Fisher-Price senior vice president and general manager Chuck Scothon testified that Fisher-Price posted recall information on its website, sent emails to registered users, worked with retailers to add signage, sought to remove the product from resale sites and worked to alert daycare centers.
Even still, Cowles told ABC News that a situation like the Rock 'n Play sleeper, where the product was not visibly broken, makes it more difficult for parents and caregivers to stop using a product, as they might not immediately notice anything wrong with it.
"In no way do they look any different than a safe product unless you're an engineer and can see the internal flaws," Cowles said. "It's not like anyone would know just by looking at a product that it has been recalled."
Holly Choi, a mother of two and co-founder of Safe Beginnings First Aid, which offers infant and toddler-focused safety workshops and courses for parents, told ABC News that in her line of work, it is not uncommon for a parent to reach out requesting for help with a baby product, only to learn the product has been recalled.
"I find that most parents are actually shocked to find out about recalls," Choi said. "When it comes to baby gear, I think there's an understanding that if it's sold on a store shelf, it must be safe, and unfortunately, we know that not to be true."
Baby products are also challenging to recall because they are often donated and swapped among family and friends, often with a high level of trust given the friends' or family members' recommendations, according to both Choi and Cowles.
"Children's products stay around for decades," Cowles said. "If the product was put away in between children at the time of the recall and parents didn't hear about it, they bring the product out and they might continue to use it for years, so that's a big problem, getting those products not just off the market, but out of homes."
The secondhand market for baby products also thrives on what experts call "survivorship bias," the idea that if something like a death or injury didn't happen to a parent or their own child, then the recall, in this case, isn't valid, according to Choi.
"We see that a lot with recalled baby products, you know, 'That doesn't happen to me. It must be the parents' fault,'" Choi said. "So there's a bit of that bias at play."
Richter said nearly five years after her daughter's death and the original Rock 'n Play Sleeper recall, she still sees the product used in people's homes on social media and on neighbors' front porches while walking through her neighborhood.
"My heart breaks. That's what it feels like every time I see one," she said, adding, "That is why I share my story, because had I heard a mother like me, I would have taken a different course of action. I'm a mother who lost her child and I'm telling you, the worst thing in my life has already happened to me."
Baby safety advocates and others push for recall change
The recall of the Fisher-Price Rock 'n Play sleeper is also an example, experts say, of how long it can take for a recall to be made public under the current system.
The CPSC issued a warning about the Rock 'n Play sleeper on April 5, 2019, advising consumers to stop using the product as soon as an infant could roll over, or by 3 months of age.
The warning said the agency was aware of 10 infant deaths related to the sleeper, dating back as far as 2015.
Just days later, the American Academy of Pediatrics called on the CPSC to recall the sleeper, citing an analysis from Consumer Reports magazine connecting it to 32 sleep-related infant deaths between 2011 and 2018.
Two days later, on April 12, 2019, the CPSC issued a recall.
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The CPSC is the government agency tasked with overseeing recalls for baby and children's products, as well as other products. For a recall to be issued, either a company itself or its consumers must report an unsafe product, and the CPSC must then decide if a recall is necessary.
What makes the CPSC unique among other federal agencies that handle recalls, consumer rights advocates say, is a provision that requires the agency to notify the manufacturer of a product and seek feedback before it can publicize information about that product. The provision, known as Section 6(b), requires the CPSC to give the manufacturer an initial 15-day period to review and send comments, and then an additional 5-day review period once the CPSC notifies the manufacturer of its position.
Section 6(b) – which was added in 1981 to the Consumer Product Safety Act, the law enacted by Congress that established the commission in 1972 – usually adds 30 to 60 days to the review process once the CPSC is aware of an issue, according to the commission.
"It creates really, really tall walls and it creates a really difficult environment where the CPSC is not really allowed to share a lot of this information with the public without the permission of the company, in most cases," Oriene Shin, product safety policy counsel for Consumer Reports, told ABC News, referring to Section 6(b). "Whenever CPSC wants to disclose safety information, they have to talk to the company and pretty much get their permission, so because of that, it can take a while for this information come out."
In February, a majority of CPSC commissioners voted to approve moving forward with changes to Section 6(b), something for which baby safety advocates, including parents like Richter, have long advocated.
The current chair of the CPSC, Alexander Hoehn-Saric issued a statement calling proposed updates to Section 6(b) "long overdue."
"Section 6(b) often prevents the CPSC from issuing timely warnings about dangerous consumer products when the Commission must negotiate with the manufacturer to make any relevant information public," Hoehn-Saric said in the statement. "When the CPSC is delayed in releasing information on product-related deaths and injuries, additional deaths or serious injuries can occur."
One month after the CPSC’s vote, in March, Democratic lawmakers reintroduced legislation, the Sunshine in Product Safety Act, that would repeal Section 6(b).
While consumer advocates are in favor of changes to Section 6(b), manufacturers of baby products argue there is important value to the CPSC working with companies to make sure any information released to the public is accurate, according to Lisa Trofe, executive director of the Juvenile Products Manufacturers Association, a U.S.-based trade association that represents companies that manufacture, sell and distribute baby products globally.
"If inaccurate information is made public and I suddenly believe I have a high chair that is dangerous but, in fact, I don't because there was some sort of inaccuracy in the information somewhere, that could just create havoc in the consumer space," Trofe told ABC News. "We believe it is really important to maintain that provision because it gives manufacturers and retailers and all product importers the opportunity to protect their brand and to make sure that the information being shared with the public is 100% accurate before it sends anyone into confusion or a panic."
In 2021, two years after the recall of the Rock ‘n Play sleeper, a congressional oversight committee report found that Fisher-Price ignored repeated warnings that its Rock 'n Play sleeper was dangerous before the device was recalled. However, weak federal oversight allowed the product to stay on the market for a decade after it was released in 2009, the report said.
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Fisher-Price said in a statement to ABC News at the time the report was released that there "is nothing more important" to the company than the safety of its products and that its "hearts go out to every family who has suffered a loss." Independent medical and other expert analyses verified that the sleeper was safe when used in accordance with its instructions and warnings, the spokesperson said.
"The Rock 'n Play Sleeper was designed and developed following extensive research, medical advice, safety analysis, and more than a year of testing and review," a Fisher-Price spokesperson said. "It met or exceeded all applicable regulatory standards. As recently as 2017, the U.S. Consumer Product Safety Commission (CPSC) proposed to adopt the ASTM voluntary standard for a 30-degree angled inclined sleeper as federal law."
Mattel, the parent company of Fisher-Price, did not reply to ABC News' request for comment for this story.
What a baby product goes through to reach store shelves
Along with the process of how baby products are recalled, safety advocates say parents and caregivers often also don't realize what happens before a baby product comes on the market.
"Parents look and, as consumers, assume that if something is on a shelf, it's on a shelf for good reason, and if it's designed for use by children or other fundamentally vulnerable communities, that it's safe, that they wouldn't sell it if it's dangerous," Dr. Benjamin Hoffman, an Oregon-based pediatrician and immediate past chair of the American Academy of Pediatrics' Council on Injury, Violence, and Poison Prevention, told ABC News. "And the fact of the matter is, there are a lot of things that are fundamentally dangerous that are sold and there are even more things that get out there that we can't say are safe."
There are a lot of things that are fundamentally dangerous that are sold.
Hoffman pointed out that, since the 1990s, safe sleep guidelines from the AAP have said that caregivers should always place infants to sleep on their backs on a firm, flat surface without any pillows, blankets or bumpers, and that infants should not be placed on inclined products for sleep.
It was only last year that legislation, known as the Safe Sleep for Babies Act, went into effect banning the manufacturing and sale of crib bumper pads and inclined sleepers for babies. Prior to that, products like the Rock 'n Play Sleeper, which places a baby at an incline, were on the market, in conflict with AAP's guidelines, according to Hoffman.
In addition to overseeing recalls, the CPSC can also set mandatory safety regulations for infant and toddler products according to different product categories, from cribs to high chairs, mattresses and more.
Once the CPSC issues a safety rule for a product category, that rule becomes mandatory for companies to follow and every product sold in the U.S. must meet that requirement. The CPSC says manufacturers are also "encouraged to comply" with voluntary safety standards set by ASTM International, an independent organization that facilitates the development of voluntary standards.
According to Trofe, federal safety standards for baby products in the U.S. can often come after the products are being used by consumers.
If there is not yet a category-specific safety rule, a baby product can still be sold, though there are some general requirements, like third-party testing, that all baby and children's products must meet.
It was not until last year, for example, that the CPSC approved a federal safety standard for infant sleep products.
"Typically the way this would unfold is that there are products on the market that are available for consumers to purchase and use at home with children. And if they're prevalent, and there is not an existing standard, then this community would work together to start to develop that standard, and ultimately get it in place as expeditiously as possible so that products that are available or, will be available at some point, could adhere to the standard and the rigors of that testing," said Trofe, adding that if a standard does not exist, a manufacturer will often work with a test lab to create safety testing for the product.
Trofe said it's important to note that products and safety standards continue to evolve.
We're continually looking at how the products are being used in the marketplace in real time.
"The science, the medical community continues to evolve and so do we, with the standard development process and the federal rulemaking that goes along behind it," she said. "We're continually looking at how the products are being used in the marketplace in real time -- what does the incident data, if any, look like -- and continuing to evolve the standard so it is ensuring that products are as safe as they can possibly be."
The Juvenile Products Manufacturers Association also has its own product certification program that consumers can look to when purchasing products, according to Trofe.
"A product that's JPMA-certified has gone above and beyond what it needs to meet federal requirements," she said. "We always encourage consumers to look for JPMA-certified when they're shopping for baby products because that means the product is as safe as it can be according to all of the testing that it's gone through before it hits the shelf."
What parents and caregivers can do
Safety experts say the first thing parents and caregivers should do when they purchase a new baby product is to fill out the registration card that comes with it so they can be notified of recalls.
"With nursery products, durable infant toddler products, there is a requirement that those come with a product registration," said Cowles. "If you get something new, register it because that's the only way companies are required to contact you if a product is recalled."
When it comes to both new and secondhand products, people should visit SaferProducts.gov, a CPSC-run website where members of the public can find recall information, read consumer complaints and report safety issues with products, according to Cowles.
Choi said people can also go to the CPSC website directly to look up the safety standards for regulated infant products like high chairs and cribs and find the most up-to-date list of recalled products.
Anytime new baby products were to enter my home, I would check the recall database.
"Anytime new baby products were to enter my home, I would check the recall database because even if something was on the store shelf, it could be recalled," Choi said.
To check the safety requirements of car seats, parents and caregivers should visit the website of the National Highway Transportation Safety Agency. The website also has an option to register car seats there to receive safety updates and recall notices, according to Choi.
With both new and hand-me-down baby products of all kinds, Choi said in addition to checking for recalls and safety notices, parents should follow a three-step checklist.
First, check to make sure the product has all its parts and is working.
Second, make sure the product is in sanitary condition.
And third, Choi said, is to make sure the product has instructions or a user's manual, which can also often be found online on the manufacturer's website.
Hoffman also urges parents and caregivers to know the safe sleep recommendations for babies issued by both the AAP and the Centers for Disease Control and Prevention, including making sure babies sleep on their back on a firm, flat sleep surface.