Food and Drug Administration

Many Americans Unaware of When Products Are Recalled

NBC 7 looked at one recent recall and how it illuminates an issue with the larger system of recalls at large

NBC Universal, Inc.

Recalls are a tool used to remove defective products, which can be dangerous, from the marketplace, but learning about a recall can be difficult.

"Literally if she didn't glance at her phone, we probably wouldn't have even known it was recalled," Ron Russak of Escondido told NBC 7 about a CPAP machine his wife uses to help her breathe while sleeping.

Philips just announced a recall of between 3 million to 4 million of their devices. The recall was made when it was learned that a foam used in the machine could degrade, possibly causing the user to inhale particles.

Russak said that if his wife hadn't seen a post on Facebook, they wouldn't have known about the recall

"My wife even called her personal physician, and they had no clue about the recall," Russak said.

The recall was announced in mid-June. Philips said customers should have received a letter from their respective medical-device supplier, but the Russaks told NBC that it never arrived.

"We started making phone calls, and, still, the medical-device supplier has not sent out any communication," Russak said.

Philips told NBC 7 that people should go online to make sure their device is registered with the company so they can be notified when a solution is available. In a statement, Philips said they do not have an estimated time to fix the issue:

Regarding estimated timing of the correction, we are working to address this issue as expeditiously as possible. However, given the number of devices currently in use (estimated at 3 t[million] o 4 million units globally based on production and shipment data – about half are in the U.S.), and that important elements of the repair and replacement program require regulatory clearances, we are not able to provide an immediate solution at this time. 

Medical devices like CPAP machines are regulated by the U.S. Food and Drug Administration. A list of all recalled models can be found on its alert page.

Philips said that people with recalled devices should talk to their physicians to determine the next steps. Device registration can be checked on Philip's page.

The FDA doesn't deal with all recalls, however. Many products are handled by the Consumer Product Safety Commission. A recent Consumer Reports investigation found a law sometimes delays important warnings from the CPSC.

Under a law known as Section 37, companies have to notify the CPSC when a certain number of lawsuits alleging serious injury or death are settled or ruled for the plaintiff within a certain period of time. But CR’s investigation found the commission rarely learns of these lawsuits.

Shortcomings in the law leave consumers exposed to potentially dangerous products. People should be aware of these lawsuits, and safety officials should be able to investigate and take action as needed.

The law, as originally proposed before it was enacted in 1990, called for companies to alert the agency about a product when a single lawsuit had been filed alleging significant injury or death, but that’s not what ultimately passed. Instead of potential issues being reported to the CPSC when a lawsuit is filed, it’s now required to be reported after three lawsuits have been settled or found in favor of the plaintiff within a specific two-year period.

Lawsuits like these often take longer than two years to resolve, so it’s rare that the CPSC finds out about these lawsuits at all. The acting chairman of the CPSC told CR, "It’s a completely disappointing and ineffective provision of law.”

In fact, over the past 25 years, only two companies have been cited for failing to report lawsuits to the CPSC. A lawyer who specializes in product-safety counseling for manufacturers said the law is fine as it currently stands, but the failures of Section 37 have consumer advocates calling for changes.

“People should know about these lawsuits, and safety officials should be able to investigate and take action as needed," said Oreine Shin, Consumer Reports' policy counsel for product safety. "Every lawsuit alleging injury or death should be reported to the CPSC when it’s filed. The agency should have all of the information it needs to keep potentially dangerous products out of people’s homes."

Even with the problems of Section 37, consumers should still regularly check to see if products they own have been recalled by the CPSC. Problems with products can also be reported on that site as well.

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