An illustration of a chicken leg to represent food recalls.
Illustration: Joan Wong

Antibiotic-resistant strains of salmonella are linked to contaminated chicken, sickening many and hospitalizing more than 200 people for almost a year and a half, though it was known that the plants processing the chicken had failed federal food safety standards. Why did the outbreak go on for so long before the unsafe chicken was pulled from store shelves?

A breast implant lacking premarket safety research is linked to a rare cancer, but years pass and women die before regulators acknowledge the connection and a manufacturer recalls the devices. Why did it take patient outcry before the potentially deadly implants were taken off the market?

An inclined sleeper for babies is put on the market without adequate safety testing or adherence to infant sleep guidelines. Over the next decade, as the sleeper becomes a best seller, dozens of babies die while using it. Why did it take public exposure before the manufacturer recalled the product?

In 21st century America, it’s easy to assume that the products we put on our plates, in our homes, and in our bodies are safe and effective. Many people expect that we have robust consumer protections in place—a system that vets products thoroughly before allowing them to be sold and that recalls products swiftly if they prove to be dangerous.

More on Recalls & Product Safety

But product safety regulation and the recall process are part of a complicated and imperfect system that varies widely depending on the type of product, the industries involved, and the government agencies tasked with overseeing it. For instance, a recall does not get put into motion automatically when a product is known to cause harm. Recalls, if they happen at all, can take years to be initiated, often only after public protest and sometimes following injuries or deaths.

Moreover, when a recall is issued, consumers often aren’t made aware. Almost 70 percent of Americans said that they had not heard about a recall in the past five years for any product they own, according to a Consumer Reports nationally representative survey of 1,010 adults, though millions of products are recalled each year. And only 21 percent of Americans said they had heard about a recall and responded to it in that time frame. Of those, about two-thirds said the issue had to do with their car, 19 percent said it involved food, 9 percent a health product, and 9 percent a children’s product.

That disparity is not surprising, says David Friedman, CR’s vice president of advocacy and a former acting administrator of the National Highway Traffic Safety Administration. Unlike other federal agencies, NHTSA requires manufacturers to notify car owners directly about recalls. To track recalls, it helps that every car has a unique vehicle identification number and every owner has a registration. Other agencies—the Food and Drug Administration, the Department of Agriculture, and the Consumer Product Safety Commission—generally have fewer tools and requirements for recalls. In some cases, laws can actually shield agencies from accountability and protect companies from liability, Friedman says.

Even when consumers learn about a recall, they often aren’t given simple, effective ways to respond. Some entail disassembling and mailing in part of the product for a refund, or not using the product until a replacement part is mailed—a process that can take months. As a result, many recalled products remain in use, risking further injury.

How, then, can consumers ensure that the products they buy have been safety tested and have not caused problems since their release? In some cases, it’s impossible to fully know. But the examples described here provide a sense of how regulatory oversight sometimes works for—and against—consumers. Plus, we share steps you can take to protect yourself and your family.

Contaminated Chicken

Noah Craten, of Glendale, Ariz., was 17 months old in October 2013 when he developed a fever that wouldn’t let up. Three weeks later, after multiple trips to the doctor, the toddler was found to have a life-threatening brain abscess caused by a bacterium called Salmonella Heidelberg.

Just before Noah got sick, his grandmother—who often ate with the family—got food poisoning and was diagnosed with a salmonella infection. But the pediatrician ruled out salmonella because the boy didn’t have severe gastro­intestinal symptoms, says Amanda Craten, Noah’s mom. Yet after Noah had brain surgery and doctors tested the abscess fluid, they learned his illness was caused by a salmonella strain traced to chicken from Foster Farms, a major poultry producer. The family regularly ate that chicken, according to a lawsuit the Cratens ultimately won against the company.

“I was sobbing when he told me it was salmonella, because I suspected it from the beginning,” Craten says.

Noah, now 7, and his grandmother were among a reported 634 people across the U.S. who became ill during a multistate salmonella outbreak linked to Foster Farms chicken that began in March 2013. It wasn’t until July 2014—16 months later—that the company issued a recall, one that included only a small portion of chicken produced over those months.

Noah still lives with a severe brain injury that impairs his speech and vision and affects his behavior. The Cratens believe the infection could have been avoided if Foster Farms had implemented stronger food safety protocols and had taken responsibility faster, and if the USDA had been able to take tougher enforcement actions.

Why didn’t Foster Farms issue a recall sooner? For one thing, it didn’t have to. The USDA’s Food Safety and Inspection Service (FSIS) can’t force food producers to recall food, even if it has sickened consumers for months. Advocates have long urged giving the USDA more recall power, something producers oppose. “It’s a big political hurdle,” says Michael Taylor, a former FSIS administrator and FDA deputy commissioner who is now co-chairman of the board of Stop Foodborne Illness, a food safety group.

What the FSIS can do: send warning letters to companies, issue public health alerts, seize products, and request a voluntary recall, among other tactics. But it’s up to the company to initiate a recall.

An FSIS spokesperson told CR that “mandatory recall authority would not enable the agency to do anything that it doesn’t already have the power to do in order to protect public health.”

Consumer advocates disagree. In the case of Foster Farms, the FSIS cited the company’s processing plants more than 480 times during the outbreak for not complying with food safety standards. Yet business was allowed to continue as people got sick. In October 2013, CR also urged the company to recall after our tests found salmonella isolated from a Foster Farms sample that matched an outbreak strain. But the chicken remained on store shelves.

A second reason Foster Farms didn’t act faster: The FSIS doesn’t consider salmonella an adulterant (a forbidden contaminant) in meat partly because it’s so common on farms and in animals, says Pat Basu, D.V.M., former FSIS chief public health veterinarian. So producers don’t have to withhold or recall chicken with the bacteria.

Instead, the burden is on the consumer “to cook the chicken well, to the recommended 165 degrees, and not cross-contaminate the kitchen,” says Francisco Diez-Gonzalez, Ph.D., director of the Center for Food Safety at the University of Georgia.

Despite that approach, salmonella still causes about 1.2 million illnesses, 23,000 hospitalizations, and 450 deaths in the U.S. each year, according to the Centers for Disease Control and Prevention.

A separate problem: The FSIS doesn’t oversee the farms where food animals are raised. That’s the jurisdiction of the USDA’s Animal and Plant Health Inspection Service, which regulates animal health and welfare, not food safety. “The USDA’s [food safety] authority begins at the threshold of the slaughterhouse and ends on the loading dock,” says Sandra Eskin, director of food safety at The Pew Charitable Trusts, a public interest group.

Yet back on the farm, “there are extremely high rates of infections,” says Taylor, the former FSIS and FDA official. “It’s a problem when you know where the issue originates yet it’s not subject to regulation.”

Other factors can delay food recalls. Diez-Gonzalez notes that it takes time, resources, and coordination between hospitals, health agencies, and patients, who have to itemize what they recently ate. “It can be a challenge to determine what sickened individuals have in common,” he says.

That difficulty not only impacts the USDA, which oversees meat and poultry, but also the FDA, which oversees most other foods, from leafy greens to packaged foods.

Last, after regulators identify a likely outbreak source, the threshold to prove a link is high. “Investigators are looking for the smoking gun,” Diez-Gonzalez says. So while hundreds of people said they’d eaten Foster Farms chicken and tested positive for an outbreak strain, the recall didn’t happen until FSIS inspectors found an unopened package of contaminated Foster Farms chicken in the freezer of a patient who’d tested positive for the same strain and had proof of its purchase.

“It’s an unreasonably narrow standard that FSIS is applying,” says Thomas Gremillion, director of food policy at the Consumer Federation of America. “It’s just bewildering.”

Since the outbreak, the FSIS estab­lished tougher standards for salmonella in chicken, and Foster Farms invested more than $75 million in food safety. When CR asked why the company didn’t recall its chicken sooner, Foster Farms declined to comment directly but noted that since April 2014, tests found salmonella in less than 5 percent of its chicken, much lower than what the USDA allows.

Though reducing salmonella in meat is a step in the right direction, “we haven’t seen that translate into reduced cases of human illness” overall, says Sarah Sorscher, a deputy director at the advocacy group Center for Science in the Public Interest. She suggests that for substantial change, farmers should do more to prevent infection by, for example, using animal vaccines.

Eskin, at Pew, argues that the USDA should have the power to enforce food safety standards from the farm to the retailer—and the power to mandate recalls.

While some in the industry support change, progress can be slow. “Sadly, it takes disasters, more outbreaks, more coverage, and more questioning by consumers,” Taylor says.

In the meantime, it’s key for consumers to curb contamination in food at home, says James E. Rogers, Ph.D., CR’s director of food safety research and testing and a former FSIS microbiologist. He advises storing meat in disposable bags apart from other foods; not washing raw meat, which spreads bacteria; using a separate cutting board for meat; washing counters, utensils, and hands after handling meat; and using a meat thermometer to ensure that you cook to recommended temperatures.

What Consumers Should Do

Respond to recalls: If a product you own has been recalled, follow the manu­facturer’s instructions—by calling the company or checking its website—on how to repair or return it. If you choose not to participate in the recall, don’t give the product away or sell it. Instead, throw it out so that it can’t be used by others.

Stay informed: Track recalls and safety alerts at recalls.gov, which will direct you to each federal agency’s recalls page. That includes the Consumer Product Safety Commission (household and other products), the Department of Agriculture (meat, poultry, and egg products), the Food and Drug Administration (most other foods, medical devices, drugs, and supplements), and the National Highway Traffic Safety Administration (vehicles, car seats, and related equipment). At each site, you can see recalls and sign up to receive email alerts. CR members can also get information about recalls related to their vehicles at CR's Car Recall Tracker.

Report problems: Each agency’s recalls page also provides a way for consumers to report problems relating to the products it regulates.

Register your products: If your product comes with a registration card, don’t toss it. Instead, fill it out and mail it in or, if possible, fill it out online. That allows the company to notify you if the product is recalled or needs a repair.

Research secondhand purchases: Though it’s illegal for retailers and individuals to sell new or used products that have been recalled, some sellers, particularly of used goods, may not adhere to this law consistently. Policies are more uneven with used-car dealers, because federal law does not explicitly prohibit the sale of used vehicles with open recalls. When buying any used product from an individual, ask for the brand, model, serial number, and date the product was manufactured. That information is often on the product itself or in the instruction manual. Also, take extra care when buying used cars; look up the VIN number on NHTSA's VIN look-up tool to see whether the car is part of a recall.

Dangerous Breast Implants

Raylene Hollrah was 33 years old in 2007 when she was diagnosed with breast cancer and underwent a mastectomy. A year and a half later, when she was ready for reconstructive surgery, she chose a silicone-filled implant with a textured surface made by Allergan. Hollrah, from Hermann, Mo., believed a selling point of the implant was that she’d automatically be enrolled in a 10-year study “so I could help other women,” she says.

What Hollrah didn’t know is that medical devices—including breast implants, artificial joints, and pacemakers—are subject to much less rigorous premarket testing than drugs are. That’s partly because the FDA didn’t begin regulating medical devices or requiring research on their efficacy and safety until 1976, after many devices were already in use.

Silicone breast implants were introduced in the 1960s with little to no safety research, says Diana Zuckerman, Ph.D., president of the National Center for Health Research. Even after the FDA began regulating them, the agency didn’t require premarket studies until 1991—when it determined there was insufficient safety research, and soon after put a moratorium on sales.

In 2006, when the FDA did approve silicone implants, it was on the condition that manufacturers conduct post-market studies, one of which included Hollrah. But that wasn’t made clear to her early on. And as time passed, more problems emerged. In 2011, the FDA announced a link between silicone- and saline-filled implants and a form of cancer called anaplastic large cell lymphoma (ALCL).

But Hollrah didn’t learn about breast implant associated ALCL, or BIA-ALCL, until 2013, when one of her implants swelled and she tested positive. “I removed breast cancer,” Hollrah says, “and then I put something right back in my body that gave me cancer again.”

Around the time of Hollrah’s diagnosis, Allergan dropped her from its post-approval study. In fact, Allergan lost track of many participants, in part because it was difficult to follow up with the women, who were given no real incentives to stay involved in the studies, Zuckerman says. As a result, the research was never completed. Yet the FDA did not penalize manufacturers or recall the implants.

Fortunately for Hollrah, her cancer was caught early. She had her implants removed in 2013 and is now cancer-free.

But it wasn’t until July 2019 that the FDA announced the recall of Allergan’s textured implants due to a reported worldwide total of 573 BIA-ALCL cases, 481 of them from Allergan, including 33 deaths.

When asked why it took eight years after the FDA acknowledged the risk of BIA-ALCL for the agency to request a recall, an FDA spokesperson said it took the action after learning, in the spring of 2019, of “a significant increase in known cases of BIA-ALCL.”

Though the recall is a victory for women affected by BIA-ALCL, other concerns remain. For one, “when medical devices are recalled, there’s typically not a rigorous process to reclaim the flawed products,” says Lisa McGiffert, a co-founder of the Patient Safety Action Network and a former patient-safety expert at CR.

There’s also no established system for device manufacturers to find and notify doctors and patients about a recall. Hollrah notes that she has yet to receive a recall notification from Allergan.

For its part, Allergan says that “patient safety is a priority” and that it is committed to ensuring the safe and effective use of its products.

Illustration: Joan Wong

Still, hundreds of thousands of women are estimated to have a recalled device in their bodies and no easy choices. The FDA recommends implant removal only for women with a diagnosis of BIA-ALCL. But women don’t always have obvious symptoms. “Although BIA-ALCL is treatable if caught early, no one wants to wait to see if they get cancer,” says Sara Castro, an attorney at Farr law firm in Punta Gorda, Fla., who is working with affected women.

Another hurdle: Though Allergan will pay for replacement implants in the case of a cancer diagnosis or implant defect, it doesn’t cover the surgical costs of preventive implant removal. Most insurers won’t cover it, either.

Scot Glasberg, M.D., past president of the American Society of Plastic Surgeons and a consultant for Allergan, says that “if a woman has any concerns whatsoever, she should see a plastic surgeon who is board certified,” specializes in breast implants, and is knowledgeable about BIA-ALCL to go over her screening and testing options.

Women considering breast-implant surgery (or any medical device procedure) should ask their surgeon for an informed consent form that details what the device contains, and known risks. “This form is not mandated yet,” says Hollrah, who did not have that protection before her surgery and has since worked with Zuckerman, Glasberg, and others to develop a patient form and clearer warnings. And they have made progress on that front: On October 24, 2019, the FDA recommended that patient labeling for breast implants include a patient decision checklist, a boxed warning, an information booklet, and a patient device card. A final decision on that recommendation isn't expected until 2020 at the earliest. 

Madris Tomes, a former program manager at the FDA who now runs Device Events—which gathers adverse event reports on medical devices—recommends researching your device. One free source is an online FDA database called MAUDE (Manufacturer and User Facility Device Experience). “Two-thirds of all recalls begin as an adverse event report,” Tomes says.

Risky Infant Sleepers

When family asked Hailey and Ty Hampton what they needed before the birth of their twin boys, Liam and Lennox, the couple didn’t hesitate: two Fisher-Price Rock ’n Play Sleepers. Other new parents were raving about them. The Hamptons, from Nauvoo, Ala., wanted the babies to sleep in the couple’s bed­room but not in their bed, which they knew was dangerous. “The Rock ’n Play Sleepers were our alternative,” Ty says.

But on Feb. 20, 2019, when Ty went to give the twins their bottles, he noticed Liam’s head was tilted oddly in the sleeper, according to a lawsuit the Hamptons filed against Fisher-Price. When Ty picked up the baby, his body was limp and cold. After frantic efforts to revive him, Liam was pronounced dead at the hospital.

The Hamptons, devastated, had no idea what caused Liam’s death. But less than two months later, they learned that dozens of other infants had died in Rock ’n Play Sleepers and that Fisher-Price and the CPSC had known about the deaths for years.

Like many parents, the Hamptons had assumed the sleeper was safe. But a CR investigation published in April found that it had never been adequately tested and posed several risks. Medical guidelines say babies should sleep on their backs, alone, unrestrained, on a firm, flat surface free of soft bedding. But the Rock ’n Play Sleeper positions babies at an angle of about 30 degrees, which may cause a baby’s head to tilt forward, compressing the airway and leading to suffocation. It also has soft padding and restraints, which increase the risks of suffocation and strangulation.

It was only after CR linked the sleepers with at least 32 infant deaths going back to at least 2011 that Fisher-Price recalled almost 5 million of them. At least 73 infants are now known to have died in these or similar sleepers.

William Wallace, CR’s manager of home and safety policy, says the recall was long overdue. “It’s outrageous that Fisher-Price and the CPSC knew about deaths linked to this product for years and didn’t take steps that could have prevented tragedies.”

When CR asked Fisher-Price in early April about the deaths associated with the Rock ’n Play Sleeper, a company spokesperson said, “We do not believe any deaths have been caused by the product,” and noted that some of the fatalities were due to mitigating circumstances or the product not being used according to instructions.

How could so many deaths not warrant a recall? At the heart of the holdup is a controversial law that restricts and sometimes prevents the CPSC from releasing company- and product-specific information, even when the products are connected to injuries or deaths.

The law, called Section 6(b) of the Consumer Product Safety Act, says that in most cases the agency must get a company’s permission before it publicly reveals a safety problem. And once a company agrees, the two negotiate the terms of the alert, which can allow the company to downplay the problem.

Proponents of 6(b) say that by giving companies a chance to review safety concerns first, the law prevents the CPSC from unfairly damaging a company’s reputation.

Critics disagree. “The gag that 6(b) places on the CPSC is a dangerous anomaly,” says CR’s Friedman. NHTSA could push “for the recall of deadly Takata airbags because we had the freedom to share what we knew,” he says. “The CPSC can’t do that.”

While the delayed recall of the Rock ’n Play Sleeper—and the lives lost while it stayed on the market—is a glaring example of what can happen when product hazards are shrouded in secrecy, it’s not an isolated case. Section 6(b) also hid for years the number of tip-over deaths associated with Ikea furniture, delaying the recall of millions of dressers.

Though the CPSC can technically mandate a recall, it rarely takes that step, in part because companies could sue the agency, says Pamela Gilbert, previously CPSC’s executive director.

The agency does not have an official stance on Section 6(b), but two members—Robert Adler, acting chairman, and Elliot Kaye, commissioner—have spoken against it. “We need the anti-consumer safety and anti-transparency requirements of Section 6(b) ... to be eliminated,” Kaye said recently. “People die because of Section 6(b). It is that simple.”

Even when recalls are initiated, it’s often hard to remove products from circulation. As CR’s recent survey showed, most Americans don’t hear about, much less respond to, product recalls. And most companies recalling products don’t face strict requirements to reach out to consumers. As a result, recall completion rates are often less than 10 percent, according to the CPSC.

In fact, 1 in 10 day care centers was still using Rock ’n Play Sleepers or other inclined sleepers months after the recalls were announced, according to a report focused on three states by U.S. PIRG and Kids in Danger (KID), two consumer-safety advocacy groups.

“Industry should make the same multifaceted efforts they do to advertise their products to notify consumers about recalls, and then take more significant steps to retrieve recalled items,” says Nancy Cowles, executive director of KID. “And government needs to be a strong advocate for consumers by enforcing product safety regulations both pre- and post-market.”

KID is one of several groups, including the American Academy of Pediatrics and CR, that urges parents not to use infant inclined sleepers and supports a bill banning them, which was introduced after the April recall.

The CPSC’s Adler explains that while recalls should be improved, “we also need to keep dangerous products from getting into the market in the first place,” he says. “You want agencies like CPSC to be the fence at the top of the cliff, not the ambulance at the bottom.”


Recalls That Made a Difference for Consumers

When seven people died in 1982 after taking Extra Strength Tylenol that had been laced with cyanide, Johnson & Johnson acted quickly and ultimately recalled 31 million bottles of the pain reliever. The Food and Drug Administration responded, too, developing standards for tamper-resistant packaging. The fast response to the still-unsolved crime became a model for how to react to safety problems. And changes such as foil seals on over-the-counter drugs show how recalls can lead to safer products. Here are eight recalls over the last 20 years that helped create a safer marketplace for consumers. —Donna Rosato

 

2000

Firestone Tires

Firestone recalled 14.4 million tires after defects caused blowouts contributing to more than 200 deaths and 500 injuries. Firestone’s slow response helped spur the TREAD Act, which requires carmakers to inform the government of potential defects and made tire pressure warning lights mandatory.

2004

Merck Vioxx

The recall of this pain drug, after being linked to heart attacks and strokes, helped lead to the Food and Drug Administration Amendments Act of 2007. The law helps prevent drug companies from downplaying side effects and gives the FDA more clout in overseeing medications.

2007

Simplicity Cribs

About a million cribs with drop-side rails were recalled after being tied to infant deaths and injuries. The recall contributed to the landmark Consumer Product Safety Improvement Act, which created SaferProducts.gov, where consumers can report and search for problems linked to products.

2008

Takata Airbags

This recall, now affecting more than 40 million vehicles with inflators that could cause airbags to rupture in crashes, prompted Honda and other automakers to use more aggressive tactics to track down open recalls, including using social media, ads at professional sports events, and hiring private detectives.

2009

Peanut Corp. of America

Hundreds of companies recalled thousands of products with salmonella-contaminated peanuts from Peanut Corp. The outbreak, which sickened more than 700 people, helped lead to the Food Safety Modernization Act, which directed the FDA to focus more on prevention.

2014

GM Ignitions

General Motors recalled 2.6 million cars due to ignition switches that shut down engines while driving. GM paid $900 million as part of a settlement of criminal charges after admitting it concealed the defect from regulators. The case boosted penalties on automakers that fail to quickly recall and repair cars.

2017

Ikea Dressers

Ikea’s recall of 17 million dressers that were unstable when not anchored to walls was a catalyst for the Stop Tip-overs of Unstable, Risky Dressers on Youth Act, which has passed the House and is now in the Senate. Tip-overs of clothing storage units have been linked to at least 206 deaths since 2000.

2019

Fisher-Price Infant Sleepers

Fisher-Price recalled nearly 5 million infant inclined sleepers after a CR investigation linked the products to dozens of deaths. After CR’s report, there were more recalls, including from Kids II for 700,000 sleepers and one by Dorel for 24,000. Legislation has also been intro­duced to ban infant inclined sleepers.

2000

Firestone Tires

Firestone recalled 14.4 million tires after defects caused blowouts contributing to more than 200 deaths and 500 injuries. Firestone’s slow response helped spur the TREAD Act, which requires carmakers to inform the government of potential defects and made tire pressure warning lights mandatory.

2004

Merck Vioxx

The recall of this pain drug, after being linked to heart attacks and strokes, helped lead to the Food and Drug Administration Amendments Act of 2007. The law helps prevent drug companies from downplaying side effects and gives the FDA more clout in overseeing medications.

2007

Simplicity Cribs

About a million cribs with drop-side rails were recalled after being tied to infant deaths and injuries. The recall contributed to the landmark Consumer Product Safety Improvement Act, which created SaferProducts.gov, where consumers can report and search for problems linked to products.

2008

Takata Airbags

This recall, now affecting more than 40 million vehicles with inflators that could cause airbags to rupture in crashes, prompted Honda and other automakers to use more aggressive tactics to track down open recalls, including using social media, ads at professional sports events, and hiring private detectives.

2009

Peanut Corp. of America

Hundreds of companies recalled thousands of products with salmonella-contaminated peanuts from Peanut Corp. The outbreak, which sickened more than 700 people, helped lead to the Food Safety Modernization Act, which directed the FDA to focus more on prevention.

2014

GM Ignitions

General Motors recalled 2.6 million cars due to ignition switches that shut down engines while driving. GM paid $900 million as part of a settlement of criminal charges after admitting it concealed the defect from regulators. The case boosted penalties on automakers that fail to quickly recall and repair cars.

2017

Ikea Dressers

Ikea’s recall of 17 million dressers that were unstable when not anchored to walls was a catalyst for the Stop Tip-overs of Unstable, Risky Dressers on Youth Act, which has passed the House and is now in the Senate. Tip-overs of clothing storage units have been linked to at least 206 deaths since 2000.

2019

Fisher-Price Infant Sleepers

Fisher-Price recalled nearly 5 million infant inclined sleepers after a CR investigation linked the products to dozens of deaths. After CR’s report, there were more recalls, including from Kids II for 700,000 sleepers and one by Dorel for 24,000. Legislation has also been intro­duced to ban infant inclined sleepers.

Editor's Note: This article also appeared in the December 2019 issue of Consumer Reports.