Updated Feb. 21, 2014 7:00 p.m. ET
One user says she developed this rash after wearing the Fitbit Force. Kim Reichelt
Fitbit said it is halting sales of its newest fitness-tracking bracelet and recalling the product after months of complaints from consumers who say the band has caused rashes on their wrists.
The voluntary recall of the Fitbit Force is a serious setback for a startup that markets its products as a way to "help people lead healthier, more active lives." It is also a public relations headache, coming days before Fitbit shows off its products in Barcelona at next week's Mobile World Congress, an annual confab for the mobile industry with tens of thousands of attendees.
The San Francisco company said in a statement that it was conducting the recall of its newest bracelet "out of an abundance of caution" and repeated an offer to refund consumers who purchased the $129 Force.
In a blog post, Fitbit Chief Executive James Park wrote that 1.7% of Force users had reported an irritation. In the company statement, Fitbit said "affected users are likely experiencing an allergic reaction" to materials in the bracelet.
Mr. Park wrote that "some users may be reacting to the nickel," a component of the stainless steel used in the device. Others, he wrote, "are likely experiencing an allergic reaction to the materials used in the strap or the adhesives used to assemble the product."
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Mr. Park repeated a statement he made in January that an independent lab had ruled out problems with the battery or electrical system.
A Fitibit spokeswoman said the company is working with the U.S. Consumer Product Safety Commission regarding the recall.
The Force is Fitbit's newest product, designed to track people's activity, such as steps taken, distance traveled and calories burned. At night, it tracks users' sleep patterns. Data can be seen on the wristband's display or on a smartphone or computer.
Soon after its release in October, wearers began complaining about blisters, rashes and itchy dry patches on their wrists. The Wall Street Journal reported last week that some of the skin problems required medical attention and prescription medication. At least one person said that she had been offered a financial settlement from Fitbit.
Since that report, the Journal has received emails from others who say they developed similar rashes from Fitbit's earlier products.
Vera Shanley, a 59-year-old medical doctor and health coach, says she developed a rash from the Fitbit One, a clip-on device that tracks fitness, sleep and nutritional patterns. Ms. Shanley bought the device when it launched in August 2012. She clipped it inside her waistband and within about a week noticed an itchy red rash developing on her right hip.
She moved the One to her left side where she also developed a rash. Now, she clips the device to her bra so that the product doesn't touch her skin. "I've had no problem with it since, whatsoever," she says.
Yvonne Beckley, 72, began wearing the Fitbit Flex bracelet in 2012. Late last year, she ordered from Fitbit different colored bands that can be used with the Flex device. When she wore the black version of the Flex band, she said she developed a rash.
Ms. Beckley saw a doctor who told her to treat the rash with an over-the-counter cortisone cream. The rash got worse, she said. Ms. Beckley returned to the doctor who then prescribed Triamcinalone, a topical steroid. The rash subsided and Ms. Beckley turned to a blue band for her Flex, which she has worn since without reaction.
A Fitbit spokeswoman said users may experience skin sensitivity with any type of wearable product, and that any issues consumers have reported with the Flex and One are unrelated to the reasons associated with the Force recall. "We take all of our consumer complaints seriously, and if any user experiences skin irritation while wearing a Fitbit device, he or she should either discontinue wearing the device or wear it attached to an article of clothing," she wrote in an email.
Fitbit is scheduled to be an exhibitor at Mobile World Congress, which starts on Monday and runs through next week. The conference has promoted on its website a contest called the Fitbit Challenge, in which attendees can buy a discounted Fitbit Flex from the Fitbit booth and win prizes based on the wearer's activity. One of the prizes was supposed to be a Force, but the company is replacing that with Flex products.
Fitbit was founded in 2007 and is backed by a number of venture-capital firms, including Foundry Group and True Ventures, which last year invested $43 million. The venture-capital firms didn't respond to requests for comment.
The Fitbit Force is displayed in the Fitbit booth at the 2014 CES in Las Vegas on Jan. 7, 2014. Getty Images
Write to Katherine Rosman at katherine.rosman@wsj.com