The Consumer Products Safety Commission (CPSC) has officially announced a recall of the Fitbit Force because of thousands of complaints of itchy rashes and burns on users' wrists while wearing the wireless wristband activity tracker.
The recall announced Wednesday is for one million units sold in the United States and about 28,000 units sold in Canada.
The CPSC received about 9,900 complaints of the wristband causing skin irritations and about 250 reports of blistering.
But Fitbit Force user Kim Reichelt, who started her own database of complaints after she claimed her wrist suffered burn-like rashes, said she has counted many more users with blistering.
"The magnitude of the impact was not even properly described," said Reichelt in an email to ABC News. "There are close to 1,000 people who have reported blistering on [Fitbit's] own forum, and that's based on posts from fewer than 10% of those who have had reactions."
Another user agreed.
"The numbers look off," said Nisha Paige of Alexandria, Va., who loved the device until she noticed an itchy rash emerge on her arm, which she initially thought was a spider bite. "[Fitbit says] only 250 people reported blisters but we have seen more reports of that on the forum. I still don't feel this recall does this issue any justice, but at least it is a legitimate recall."
The CPSC recall notice attributed the reaction to "the stainless steel casing, materials used in the strap, or adhesives used to assemble the product, resulting in redness, rashes or blistering where the skin has been in contact with the tracker."
In a statement, Fitbit said that "a thorough analysis by independent labs and medical experts revealed that the reactions reported by a small percentage of Force users were likely the result of allergic contact dermatitis."
The company added it has been working with medical experts to figure out the cause of the skin issues, just as it pointed out that the surgical grade stainless steel in the device met the most stringent regulatory standards.
George Cobb of Bozeman, Mont., has fears about the device, which he purchased as a gift for his girlfriend.
"The bigger issue is dealing with the unknown. Is this a carcinogen reaction? Will it affect her immune system? I'm sick over this," he wrote in an email. "A gift that was meant to promote health has turned into a nightmare."
Sixty-two year old Tandika Star said she wore the Fitbit Force for about 10 days before a burn-like rash emerged.
"I'm horrified by the way this problem has been handled by Fitbit, Inc.," she said. "They have not released any information about what chemical[s] we have been infected with and if these will cause breast cancer, birth defects, or long term debilitation."
The maker of what's been called the most popular fitness tracker on the market had previously issued a voluntary recall of the $129 Fitbit Force device on Feb. 21, offering refunds to customers who wanted one. The company also stopped selling the device. But many users did not hear about that recall because it did not go through official government channels, like Wednesday's recall, which now makes it illegal to sell or resell the Force device.
"I am appalled that Fitbit has not notified all owners of the device while hundreds more continue to get hurt," said Alexandra Schweitzer, who said her rash took weeks to clear up.
A spokesperson from CPSC said the agency "expects Fitbit to use their social media platforms, including Twitter and Facebook, to inform consumers about the recall of the Fitbit Force. In addition, Fitbit should use their customer contact information to directly notify affected consumers about this important recall."
A visit to Fitbit's homepage revealed no information about the recall, but after clicking on the "Products" tab and selecting "Force Wireless Activity and Wristband," a pop-up revealed details of the recall along with a request to sign up for more information on "our next generation tracker."
The company said it will be emailing all Force users over the next few weeks so that they are aware of the recall and offer a refund for full retail price. In the meantime, Fitbit Force users should call 1-888-656-6381 or visit http://www.fitbit.com/forcesupport for information on how to receive a refund for their recalled device.