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How NOT to conduct a recall: Fitbit’s rash decisions

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Wherever I go or travel, I wear a fitness tracker, and I rely on it to track my progress. But I never expected that a pursuit of a healthy lifestyle would injure me. Yet, I was injured by the Fitbit Force. The manufacturer of the Force, Fitbit, was one of the first, and certainly the most prolific, in the wearable fitness industry. Accordingly, they have built an avid, if not rabid, fan base that became dependent on their trackers. When it was reported that their newest health tracker, the Force, was actually injuring many thousands of users, the uninjured faithful scoffed at the reports, derided the injured, and refused to adhere to the recall of their beloved product. This is the real story of what happened, and where things stand today.

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First there was the Flex
When Fitbit announced its first tracker band, the Flex, last May, I enthusiastically embraced it and strapped it onto my wrist (although with unnecessary difficulty). However, it had shortcomings, such as limited battery life, difficulty charging, and no readout. Consequently, when Fitbit announced its “new and improved” tracker, the Force, I preordered it and was one of the first to receive it.

Then came the Force, followed by the “rash”
The Force was an effective no-brainer tracker, and the app was simple and easy to use. Although even more difficult to put on than the Flex, its battery life was longer, it was easier to charge, and it had a readout, albeit small. For about 3 months, I wore the Force everywhere, day and night (except showering). It was my world-wide constant companion on the road to good health! Or so I thought. Then I noticed two angry red bumps on my wrist, just under the band’s battery leads. I tried cortisone creams and cleaned the area carefully, but nothing helped. Instead it began to get larger, redder, more swollen, and it eventually blistered. When I switched the Force to the other wrist, not only did the first wrist not heal, but within days the second wrist developed the same “rash” which also kept getting redder and bigger.

How could my health device be injuring me?
While desperately searching for information about my mysterious rash, I found the Fitbit Forum, where hundreds of users described and posted photos of rashes identical to mine. In literally thousands of posts, users demanded answers from Fitbit, who trivialized the reaction by saying that only “a small percentage” of people with sensitive skin have had a slight reaction, and likely have allergic reactions to a lot of things. But I knew that my rash, which had turned into a burn, was unlike any allergic reaction I had ever experienced. The rash/burn seemed to be taking on a life of its own, gaining ground even after removing the band!

My doctor was dumbfounded by the injury, but said it was likely not a typical rash or allergic reaction. She said it appeared to have burned deeply into the dermis of my skin. She could not explain why it was continuing to get worse, grow and blister and ooze.

Fitbit underplayed the issue
When contacted, Fitbit issued the same patronizing boilerplate statement about a “small percentage” of sensitive individuals having a “slight” allergic reaction. Fitbit has never conceded that it is anything more serious than a “skin irritation”, which is innocuous at best and demeaning at worst. They then disclosed there was nickel in the “surgical grade” stainless steel used in the band’s tracker. Yet, when asked, Fitbit would not divulge the amount of nickel content, other than saying it was "a trace". They instead insisted that information was “proprietary”. As other similar products and endless watch and jewelry items contain “traces” of nickel, it was hard to imagine that a "trace" could be harmful, in spite of the fact that Fitbit had originally failed to disclose it. Most users maintained that they had no allergic reaction when exposed to nickel in the past.

The one commonality among most physicians' opinions was that they had no idea what caused this red, angry, oozing burn, or why it continued to get worse even after removing the Force. By and large doctors counseled their patients to find out what the irritant was, as that was the only way they could try to deal with it. Some users reported repeat reactions long after they had removed the band, often months after the initial rash had healed. Meanwhile, Fitbit seemed to be cheerleading the uninjured angry mobs by continually trivializing the "small percentage" of people with “sensitive skin” and promising the faithful new features, upgrades, caller ID, and even a forthcoming designer Tory Burch Force. Fitbit exhibited no concern that their Forces were the only fitness products on the market causing so many reactions. But, they must surely have known that something was going on. They not only kept the secret of the irritant, but kept selling the injurious and defective devices.

Was Fitbit cornered into a “voluntary” recall?
The Force was “voluntarily recalled” on February 20th due to a “small percentage” of users encountering a “minor skin irritation”. Meanwhile, my angry red “minor irritation” continued to fester and disfigure my wrist and appeared to be scarring. Fitbit was aware that the US Consumer Product Safety Commission was receiving numerous complaints and would likely become involved. So Fitbit staged their own “voluntary recall” before the US CPSC would have a chance to impose one on them. Only then, did Fitbit make a feeble attempt to claim the moral high ground.

Soon afterwards, the US CPSC did become involved, and made it illegal to sell the Force. Fitbit was legally required to notify all users of the “voluntary recall” and apprise them of their right to a refund. I immediately requested my return kit, which took about a month to arrive. An apology of sorts appeared on Fitbit’s website, where the story had by then changed to describe the injury as “allergic contact dermatitis” which came from “commonly used materials” in the device’s manufacture. The implication was that Fitbit had magnanimously agreed to voluntarily recall and stop selling the product.

Fitbit’s Force user injury forum flooded then drained. The first report to the CPSC was made on January 14, 2014. After that and numerous media articles, the Fitbit Forum was swelling with both angry injured users demanding answers and rabid loyalists demeaning the injured. After all, they reasoned, it was the fault of the whiney injured that their beloved Force was withdrawn. The forum moderators underplayed the problem, in spite of the many hundreds of forum pages dedicated to it. Forum participants related that diabetics were told by their doctors to discontinue use of the Force immediately, as that type of festering wound could be life threatening to them. Nursing and pregnant mothers were advised by their physicians to immediately discontinue use to avoid transmitting “whatever it was” to their babies. Yet, throughout this melee, Fitbit stayed tight-lipped, refusing to be helpful or answer any questions. Then the posts of negative commenters began to dwindle, as the posters were banned. The vitriol from rabid pro-Force posters still continues to be seen in their forum, such as: “…The 10,000 owners or 1% of the total Force users out there could have…sent it back for a refund or put lotion on it rather than demand a recall. I had NO irritation… Fitbit has done a super job supporting a return policy…It’s heartbreaking to see what a few did to a fine piece of equipment.”

Fitbit’s questionable figures
Now the real questions began. First of all, there is every reason to suspect that even Fitbit's initially reported numbers of those injured were incorrect. We have only Fitbit’s word. It is a finite number (accurate or inaccurate) supposedly derived from statistics prior to February 20, 2014 (most likely from January 2014). However, since the recall and CPSC involvement, the numbers of the injured have steadily increased. Furthermore, Fitbit's reporting was woefully incomplete, as not everyone with a reaction reported it to Fitbit, but Fitbit used only those that did.

It is believed that Fitbit cited the entire number of units produced and saleable in their published equation, rather than only those sold, registered and owned. In fact, only about ½ of those cited were actually purchased and registered at that time. Their figures also included units still at stores or too recently sold to be worn long enough to generate a reaction (rashes typically took 1 ½-2 months to develop). Their figures also included unworn units and those returned for other defective reasons such as the common broken band or dead battery issues. Even IF we accept their 1.7% number, it was only pertinent through January-February 2014. Fitbit subsequently confirmed on their website that with a 1.7% reaction rate and 9900 reactions, the real number of sales was 582,000. Since the recall, online reports have greatly increased. With some reasonable assumptions, we can estimate that what may have been 1.7% then, would be about 4.1% now.

With all the uproar, the US CPSC involvement, and the “voluntary recall”, the company “line” for the cause then changed to “skin irritations most likely due to reactions to the adhesive, band or other materials involved in the manufacture”.

The required user notification of the “voluntary” recall was a joke
To this day, not everyone who has worn and registered their Fitbit Force has been notified of the potential danger and their right to a refund. Fitbit has had over 4 months to complete this relatively simple notification process, but hasn’t abided by the mandate from the CPSC. And, the only ones they “attempted” to alert were those with a Force paired to their account as of a certain date. Anyone who had unpaired their device for any reason or amount of time, or anyone who didn’t use their app with the website, got no notification. Some users actually did receive the notification, but, as it looked like a phishing email, most recipients were afraid to open it, or instantly trashed it. This "notification" was sent as a Microsoft Word attachment to an email, sent not from a recognizable Fitbit email address, but one completely unfamiliar to any wearer. Any careful computer user would be reluctant to open such an email, and we know from Twitter posts from confused users that many did not. There was no notice of the recall posted on our Fitbit Dashboards where we constantly logged in to see our progress. There were no mailed notices to many of the registered Fitbit Force owners. Fitbit had instant access, not only to all our email and mailing addresses, but to all of our personal information, as well. Ironically, it has since been publicized that Fitbit made money by selling personal fitness information to other companies.

When users were able to find out about and avail themselves of the return process, even the refund checks looked like junk mail. Many recipients discarded them, as there was no indication that they were sent by Fitbit or as a result of the recall. The refunds came from the ominous-sounding Stericycle.

Many uninformed became the injured
Fitbit’s figures for those injured by the Force were published in February, while the Force was launched the previous October/November. In the 4+ months since the “voluntary recall” untold scores of uninformed users continued to be in danger of, and many were injured by, this mysterious rash/burn. To this day, users are still posting about their surprise at being injured by their Forces. They can’t understand why Fitbit didn’t notify them, since they get all Fitbit’s weekly fitness reports and advertising.

Lawsuit participants banned from Fitbit’s “public” forum
In some cases, it is theorized that some of the suddenly missing forum posts were banned due to the poster's participation in the class action or mass tort lawsuits filed against Fitbit on behalf of those injured. Ironically, many of participants of the lawsuit actually joined out of concern for their long-term health consequences, rather than financial gain. However, Fitbit did a huge disservice to their community by removing the links that enabled anyone to add to or learn from the list of those affected. They also removed the links that told how to report to the CPSC, thus limiting those negative reports against them.

Scientific professionals forced to speculate on the cause of the injuries
Because Fitbit refuses to release any specific information as to what caused the injury, those injured have been forced to consult physicians, chemists, and scientists, some of whose knowledgeable speculations are frightening. Nursing and pregnant mothers are desperate to find out if their “contamination” will be harmful to their current or future children. Those with compromised immune systems worry that they will be further compromised.

Users, too, began to investigate on their own and speculate from their findings. It was learned that Chinese companies were accused of using radioactive materials from near the Fukushima nuclear site. Some users tested their units with Geiger counters and one even posted a photo of a Force glowing under a UV light. Considering the mysterious nature of the injuries and the refusal of Fitbit to disclose the actual cause, nothing was too awful to contemplate.

Desperately seeking withheld information; those injured have discovered that their injuries are consistent with radiation and radioactivity. Others remark that the injuries seem consistent lead exposure. But, the bottom line is that NO ONE but Fitbit knows what causes the injuries, and they won’t tell the injured.

Fitbit continued to minimize the issue and changed the story to include adhesives
Fitbit has minimized these concerns by saying that the adhesives used in the manufacture of the band are those used in many types of electronics. However, science and common sense dictate that most types of electronics are not meant to be worn against the skin 24/7. In fact, warnings are usually issued that, in the event of a leak or other type of exposure, one should seek immediate medical attention.

The RoHS (Restriction of Hazardous Substances) seal of compliance is on each Force box. Chemicals in adhesives typically used for such purposes range from benzene to isocyanates to acrylics, all of which could have serious health consequences. However, this is relatively meaningless as the enforcement for that depends entirely on the laws of the country where the product is manufactured. Fitbit is made in China, and China’s enforcement (if it exists at all) is not comparable to that of the US or many other countries. Think of lead paint on children’s toys, contaminated food and medications, and other horror stories from chronic lack of oversight in that country. Yet, despite the product being recalled, our weak enforcement laws do not obligate Fitbit to disclose the offending agents or the degree of health risk.

Force units are returned to a hazardous waste disposal company. Although aware of all the consumer injury and outrage, Fitbit made only a feeble and “misguided” attempt to inform its users of the potential danger and return option. Those who did opt to return the band eventually received a mail-back envelope addressed to Stericycle, not Fitbit. Stericycle is a hazardous waste disposal company. Those returned units seemed destined for destruction, rather than being used for research and testing purposes. Clearly, Fitbit already knew the cause of the injuries.

Meanwhile, Fitbit continued to subvert the intention of the recall by encouraging “loyalists” who didn’t want to return their units. Rather than observe the recall, Fitbit continues to tell users that the choice of whether or not to return the recalled device is “up to the user”. Furthermore, Fitbit made it clear that anyone who had lost his Force could opt to receive a Flex in lieu of a refund. It is illegal to offer to exchange a product when the recall specifies a refund.

Fitbit got its second wind
Just when banning adverse forum posts and posters, and not effectively notifying their client base, failed to quell the outrage from many thousands of injured users, Fitbit appeared to get its second wind. Suddenly every imaginable media source began touting the defunct Force’s ”dominance” over all competitors. They easily overlooked the fact that Fitbit’s Force sales numbers should be questioned. Fitbit clearly didn’t net out Forces returned, yet apparently did include replacement sales of their old products, the Flex and the One.

Most articles appeared to derive from a Canalyst report claiming that Fitbit accounted for 50% of the 2.7 million wearable bands shipped worldwide in January-March of 2014. They also claimed that Fitbit kept its lead despite the voluntary recall. However, the article failed to point out that the voluntary recall came towards the END of the first quarter of 2014. It wasn’t until almost the end of that same quarter that the US Consumer Protection Safety Commission enforced the recall (March 12, 2014).

Fitbit continued to market defective Force to other countries
At this point in time, even after their initial recall in the US, there was evidence that Fitbit was actively marketing the Force to other countries such as Korea, the Netherlands, and even the UK. A March article in the Korean Times enthusiastically quotes Fitbit's Korea Manager as saying: "Korea is a truly important market for us. Responses by Koreans to our products will help us strengthen our product awareness in other key Asian markets, including China". Fitbit continues to maintain Force web pages for several other countries, even providing links to stores where the devices can be purchased. Many of the articles harkened back to 2013, where, again, Fitbit claimed they “shipped the most activity trackers in 2013”. No one seems to question that the product safety recall was not until 2014 for those same trackers, and not all “shipped” trackers were purchased and worn. The following is an entry on the Fitbit UK forum by James Cheadle Photography. He was able to receive a Force as recently as May, and is complaining that “it wouldn’t stay on my wrist. In fact it was falling off on an almost daily basis due to the shockingly bad designed strap…and it’s now lost due to falling off my wrist one time too many. What a waste of money…”. There is no indication that users in other countries are even aware of the thousands of injuries sustained in the US or the safety recall here.

The “rashless” eventually got burned
It became all too commonplace to see users totally stunned by their “rashes” which finally appeared from the recalled band they had refused to return. One of the higher profile of the “rashless” was Chris Velazco, a writer for Engadget, who was a self-proclaimed “Golden God”, untouchable by the scourge that burned the rest of us. Until he tweeted that he, too, got burned, and got angry.

Forces are still in store displays and sold on EBay and Craig’s List
Craig’s List and eBay continued listing the recalled and illegal-to-sell Forces for often many times the purchase amount. There is even a recent Craig’s List listing for the Force from someone who acknowledged that he was selling it because he got the rash—and his selling price was for considerably more than he paid for it. In the listing, he even admitted that he chose to sell it because he could make more money selling it than he could from the refund. EBay has their work cut out for them, as on any given day you can often see Forces listed for upwards of $400 (for the $130 recalled device).

No lesson learned, now other Fitbit products are proving defective and harmful
In spite of the lessons that COULD have been learned from this failed recall, another problem is currently gaining ground. An alarmingly large number of Fitbit Flex users have discovered that the Flex, as well as the Force, is giving them similar blistering rash/burn reactions. Still no word from Fitbit as to what could be causing any of these serious injuries, and no recall effort for the Flex! Flexes are still being sold, and even given by Fitbit in lieu of a refund for the Force. An exhaustive collection of publicly reported Flex rashes on social media sites indicates that, when professionally extrapolated, there have been at least 4000 Flex rash/burn injuries to date. And now, reports are starting to come in that users are getting eerily similar injuries from their Fitbit One clip-on devices.

Forces not only burn users, but also self-destruct
Furthermore, there is a “rash” of Forces falling apart, with the band breaking away from the tracker housing. Even some existing store displays of the Force show them broken. Desperate users are posting “fixes” to try to keep their Forces together. Some even look for ways to replace the band on their defective Force. However, it is the entire Force that is defective, certainly not only the band. If you maintain the display part, you are undoubtedly retaining some of the offending adhesive. Now reports are flooding the social media of Flexes falling apart, as well as Forces.

Fitbit allowed the uninformed to become victims
Fitbit did so much more than creating a faulty, potentially dangerous product—they allowed countless unnotified users to become injured after the recall due to the users’ ignorance of the potential dangers and refund options. This was one of the poorest recalls imaginable. And even those of us injured who DID find out about the recall and DID return the band, still have no way of knowing what injured and scarred us. We don’t know if that dangerous substance is a carcinogen, or if it will have a future impact on our health.

Many thousands of us had our horrible oozing, blistering, long-lasting and sometimes scarring injuries trivialized by Fitbit, who mislead others, and complied with only the barest minimum of the recall requirements. Long afterwards, even though not being allowed to sell the product, the Force was still shown on their website and on store displays, and they continued to support the hardware by replacing lost and broken parts. Their forums not only don’t discourage use of the Force, rather they arbitrarily ban any user who offers advice and information contrary to that issued by Fitbit. They continue to cheer loyal Force users, and tell them it is up to the user whether or not to return the Force, and Fitbit continues to promise yet another band is in the works.

Those of us injured by Fitbit's secret mysterious substance are concerned about the long-term ramifications and dangers of this exposure, and the likelihood of the rash/burn returning (which some have already reported). It seems clear that the problem is not limited to the Force, as Flex users are developing similar reactions in alarming numbers. And now reports of Fitbit’s One causing similar injuries are surfacing.

It raises questions about the safety of Fitbit’s entire product line, all presumably manufactured in the same place with the same or similar materials. Also of concern is that:

  • Fitbit never made any further attempt to question users returning the Force
  • Not appearing to be concerned whether or not the user had a reaction
  • Fitbit appears to feel free to discourage the recall, as evidenced by their weak notification method
  • Promising those who retain the defective Force future software enhancements
  • They persisted in pairing the word “voluntary” with every reference to the recall, inferring to users that compliance with the letter of the recall is not really mandatory.
  • They have disabled any ability for those affected to share their experiences, thus denying users the chance to try to determine a cause and possibly prevent repeat reactions.
  • They now are actively promising an imminent new and improved tracker, with none of the “irritations” of the Force. That implies that they know what caused the Force to injure thousands, or else they wouldn’t be able to promise a new "allergen-free" product.

Yet, WE don’t know, and Fitbit is intentionally keeping that information from us.

It is estimated that there have been a minimum of 23,333 Force injuries reported, and at least 4,000 Flex injuries reported (extrapolated from the over 250 found by searching the forums). Fitbit One rash reports are just beginning to show up.

For those who wish to record or report their injury:

Form to enter data:
https://docs.google.com/forms/d/1QsBzNB3AcFJ4FWmfAZroHWGMsSKZY5UqWgXBFYbzeNA/viewform

Fitbit Force rash data spreadsheet:
https://docs.google.com/spreadsheet/pub?key=0ArLcGts0wGGOdDJZbHo3UF9GODdZSkJuS2MyanNER1E&single=true&gid=2&output=html

Fitbit Flex Rash Reports:
https://docs.google.com/document/d/1PqEn_Fd66jE0jydtKCLMtwZNqTpK6Siz9yJoonrd9DI/edit

Flex rashes that look or sound like Force rashes: https://docs.google.com/document/d/1dL6aniu1uEO6BBPxj1LL5QLRqy_dfuXgaf80Ne00Ylc/edit

To report your rash or burn to the CPSC: https://www.saferproducts.gov/CPSRMSPublic/Incidents/ReportIncident.aspx

An incredible website for accurate Force recall historical data on the problem, relevant through March 2014: http://fitbitforcerecall.com

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