How Recalls Work (And Don’t) And Why They’re All So Different

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Manufacturers — of all kinds — usually try hard to get it right on the first try. From banana muffins to bicycle helmets, it’s in a company’s best interests to make their products perfect. Not only is it better for their reputation and their business, but it’s less expensive, in the long run, and causes less trouble. Sometimes, though, something just goes wrong.

A design flaw you don’t notice until it’s in the wild a hundred thousand times. A sensitivity you’d have no way of discovering if you didn’t test on a wide enough array of people. A couple hundred mice in the factory wreaking havoc on the production line. Whatever the cause, crap happens and sometimes products need to be recalled.

So where do recalls come from, and how are they handled? That’s where it gets tricky.

The government maintains a one-stop shop website for listing recalls, but there is no National Bureau of Recalls… as much as it might help consumers if there were. Instead, a patchwork arrangement of four independent agencies is responsible for consumers’ health and safety.

The agencies each cover a different aspect of health and safety — food, cars, medicines, household goods, and so on — and each of the four has a different process for initiating recalls and notifying consumers. Here’s how it all works.

Things You Can Eat

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Two agencies split authority for food safety in the US.

In general, if you or a furry member of your household can ingest something in any way, the FDA is responsible. That agency has authority over food and drugs for both humans and animals. But there’s one big caveat: if meat, poultry, or eggs are involved in any way whatsoever, the FDA doesn’t have jurisdiction — the USDA does.

Confused yet? You probably should be. This one’s weird.

To simplify, think of it as the pepperoni pizza paradox: something gets into the factory line at FrozenCo and contaminates their frozen pizza assembly. FrozenCo makes cheese pizzas, veggie pizzas, pepperoni pizzas, and supreme pizzas. All four are made on the same line, and have the same contaminant — but the pepperoni and supreme pizzas will be recalled under the auspices of the USDA, and the cheese and veggie ones under the auspices of the FDA.

The Obama administration has proposed creating a single food safety agency but for the time being, the split remains.

The United States Department of Agriculture (USDA)

The USDA handles recalls related to meat, poultry, and eggs, through a division of the agency called FSIS (the Food Safety and Inspection Service).

How they start: Food safety recalls can be triggered in one of four general ways.

  1. A state or federal inspection of a facility turns up a problem
  2. A manufacturer or distributor discovers something wrong on their own, and notifies the FSIS
  3. A food item fails in a random sampling program
  4. Someone somewhere gets sick from a food item, and state health departments notify the feds

Consumers can also initiate complaints about food safety, although in most cases they still have to go through a chain of state-level agencies.

What merits a recall: Basically, the USDA asks for a recall if meat, poultry, or eggs are (1) adulterated — meaning they’re likely to cause harm or are generally unfit for human consumption, or (2) mis-branded — shipped or sold in “false or misleading” labeling or packaging.

The USDA takes a three-tiered approach to classifying recall seriousness.

  • Class I: A “health hazard situation” with “reasonable probability” that the food in question will hurt or kill you.
  • Class II: Also a health hazard situation, but with a very low risk of adverse health consequences.
  • Class III: Consuming the food in question will not hurt or kill you.

So if something is full of ground glass? That’s a Class I situation. If labels about, say, a product’s farm of origin got switched on the line? Class III.

What doesn’t get a recall: Recalls are really specific. So if 100 people have gotten salmonella from something, but that something can’t be identified — as happens — the best FSIS can do is issue a public health alert, warning customers that something is making people sick but it’s not yet pinned down, and reiterating best practices in food safety.

Who does the recalling: It’s not actually FSIS that does the recalling, it’s the food companies. Recalls are all voluntary actions — meaning, not done with a legal compulsion like a court order — that companies can either initiate all on their own, or that FSIS can ask them to do. No company has ever yet refused to initiate a recall when requested.

What happens if a company won’t recall something: If there’s a dangerously contaminated product out there and the company that made it for some reason won’t issue a recall, FSIS has the legal authority to seize the product and prevent it from going out to consumers.

Food and Drug Administration (FDA)

The FDA covers a pretty big range of items. Food (both human and animal) and drugs (again, both human and animal) are right there in the name.

“Drugs” run the gamut from aspirin to Zoloft and include tobacco products. But the FDA also covers a wide array of medical items related to “drugs,” including medical devices, blood, and transplantable tissue.

As a result, there are slightly different sets of regulation applying to the procedures for recalling food; drugs; medical devices; radiation-emitting products; vaccines, blood, and biologics; animal and veterinary; cosmetics; and tobacco products. But in general, they all focus on the same ideas.

There are also two exceptions to the FDA’s food recall authority. Beer, wine, and liquor fall under the auspices of the Bureau of Alcohol, Tobacco, and Firearms which works in tandem with the FDA, and shellfish — both fresh and frozen — are managed by an organization called the ISSC.

How they start: FDA recalls — across all product categories — can be triggered in one of four general ways.

  1. A company discovers they have a problem and contacts the FDA
  2. An FDA inspection of a facility turns up problems that merit a recall
  3. The CDC contacts the FDA about foodborne illness reports
  4. The FDA learns about a problem through reports from other (state, local, etc) health reporting systems

What merits a recall: The FDA has three general concerns. They want to know if a product is harmful, if it is defective, or if it is in some other way in violation of the laws and regulations under its purview.

Like the USDA, the FDA considers recalls to be in one of three classes:

  • Class I: products that have a “reasonable likelihood” of “serious adverse health consequences or death.” Things that will badly hurt or kill you.
  • Class II: Things that might cause harm, but in a “temporary or medically reversible” way and which have “remote” chances of causing severe harm or death.
  • Class III: Things that are not likely to cause adverse health consequences, but that still violate legal regulations in some way.

If your corn-only cereal gets contaminated and ends up being a big ol’ box of unlabeled peanut-Os, that’s a Class I. If your printing run for a label cuts off the product size, that’s Class III.

What doesn’t get a recall: When something has gone wrong but isn’t part of the manufacturing chain, that’s not a recall. It’s a “market withdrawal.” The FDA gives the example of a product that was tampered with after being distributed to retailers.

Who does the recalling: The company that manufactured or distributed the problem item does the recalling. A recall is, in general, a voluntary action by business. That voluntary action can either start with the business, or can be requested by the FDA.

However, the FDA does have the authority to mandate certain recalls. The FDA can issue a mandatory recall of infant formula and certain medical devices, biological products, and transplantable human tissue.

The FDA also gained the authority to issue a mandatory food product recall in 2011. As of just a few weeks ago, however, the guidance for industry about mandatory food recalls was still in draft form and not in effect.

What happens if a company won’t recall something: Thanks to that mandatory recall authority, if the product in question is a certain kind of medical device, biological product, human tissue, infant formula, tobacco product, or food, then the FDA can order a recall and the company’s wants no longer figure into it.

First, the FDA asks a company to conduct a voluntary recall. If they can’t or won’t act fast enough, the head of the FDA can then order the company to “cease distribution and to give notice to other persons in the distribution chain.”

Prior to the change in recall authority, the FDA had to rely on compliance with voluntary recall requests or to get a court order requiring the company to initiate a recall.

Things That Make You Go Vroom

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Thanks to General Motors and Takata, we’ve heard a lot more than usual about car safety and recalls over the past year. That’s where NHTSA comes in.

If you can drive it, or if it’s essential to the safety of the vehicle or its passengers, NHSTA regulates it. The agency is responsible for road safety overall, and that mandate includes oversight of cars, trucks, and motorcycles as well as tires and child safety car seats.

National Highway Traffic Safety Administration (NHTSA)

How they start: Most car recalls start with consumer complaints.

NHTSA screens the complaints that come in, and has a look for both commonalities and severity. If a significant number of people all report the same problem (or variations on the same problem), even if it’s relatively minor, that’s something to investigate further. Alternatively, if only a few complaints come in but the problem is huge and obviously dangerous, that, too, is something to investigate further.

Vehicle manufacturers can also initiate a recall on their own, before (or without) telling NHTSA.

What merits a recall: Safety issues. If your car is likely to shut off or lose steering while you’re at highway speeds, or the seat belts don’t actually work, or the airbags kill you instead of protecting you… that’s a recall.

What doesn’t get a recall: Irritants that do not pose safety hazards. NHTSA includes paint quality, air conditioners, and radios in its examples of parts failures that wouldn’t merit a safety recall.

Who does the recalling: Once again, manufacturers — not NHTSA — are the actual recalling bodies.

What happens if a company won’t recall something: There have been high-profile cases in recent months of companies dragging their heels on major recalls. When NHTSA feels a significant safety flaw isn’t being addressed quickly or thoroughly enough, the agency can get a court order compelling the recall — though generally, the threat of being dragged into court does seem to make companies comply.

NHTSA can also issue fines for failure to report safety issues, as well as for failing to cooperate with investigations.

Absolutely Everything Else

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Look around. Whatever room you’re in is completely chock-full of stuff that isn’t food, drink, drug, or car-related. All of those things you can buy, from alphabet blocks to zithers, are consumer products.

All of those products — baby and kid stuff, toys, office goods, electronics, bicycles, sporting equipment, and basically any other non-food, non-car physical item you can think of — fall under the auspices of the CPSC. Other than the products and vehicles covered by other agencies, there’s just one notable exception: firearms, which are not subject to safety oversight from any federal agency.

Consumer Product Safety Commission (CPSC)

How they start: Product recalls for CPSC-regulated items can follow one of two general paths:

  1. Through whatever means, the company realizes they have a problem, initiates a recall, and reaches out to the CPSC, or
  2. The CPSC receives reports of problems from consumers and other sources (like media reports), and reaches out to the company to have them initiate a recall

The CPSC strongly encourages businesses to have a recall plan, to have their act together, and for them to initiate recalls first through a “fast track” program.

What merits a recall: Safety issues, health hazards, and design flaws or manufacturing defects that may cause those things.

It’s a broad description but then, the CPSC has a broad mandate. Our regular monthly recall roundup highlights several examples. Specific recent cases include a recall on Beats Pill speakers for being a fire hazard, or the Fitbit Force for causing rashes.

The CPSC guidance for businesses lists the things that businesses have a legal duty to report:

  • A defective product that could create a substantial risk of injury to consumers
  • A product that creates an unreasonable risk of serious injury or death
  • A product that fails to comply with an applicable consumer product safety rule or with any other rule, regulation, standard, or ban under … any statute enforced by the CPSC
  • An incident in which a child (regardless of age) chokes on a marble, small ball, latex balloon, or other small part contained in a toy or game and that, as a result of the incident, the child dies, suffers serious injury, ceases breathing for any length of time, or is treated by a medical professional
  • Certain types of lawsuits. (This applies to manufacturers and importers only)

What doesn’t get a recall: Things that kind of suck, but are not health or safety hazards likely to hurt a person, pet, or property.

If your pool noodle doesn’t float, well, that’s a crappy pool noodle and you should buy a better one next time. If your pool noodle leaches toxic or illegal chemicals into your pool and can cause rashes or illness, that’s a recall.

Who does the recalling: As with all other agencies, it is actually the company that made the product that does the recalling.

However, the onus is even more strongly on the business when it comes to CPSC-regulated items than with everything else. The agency pushes hard to get companies to report early and fast track their recalls wherever possible.

What happens if a company won’t recall something: That’s when it gets ugly and the courts get involved.

The CPSC has to go get a court order to be permitted to force a recall. It’s a lengthy process that the last few years have given us a clear demonstration of, thanks to Buckyballs. The product, a small, strong, rare-earth magnet toy, was frequently swallowed by young children and could cause severe injury to the kids when that happened. The company refused to recall the item, however.

So in 2012, the CPSC filed a complaint against the toy’s maker. After that many retailers voluntarily pulled the item from their shelves. The company fought back but then closed. Since the company no longer existed to be sued, the CPSC said they would target the owner, who could then be found liable for up to $57 million in consumer refunds.

A few months later, the CPSC and the founder came to a settlement that allowed the agency finally to kick off a formal recall process that would allow consumers to claim refunds.

It’s very uncommon for the agency to need to go to such lengths to compel a recall. Prior to the Buckyballs case, the last time the CPSC had to sue to get a product recalled was in 2003.

Want more consumer news? Visit our parent organization, Consumer Reports, for the latest on scams, recalls, and other consumer issues.