Owlet Smart Socks

Bed Bath & Beyond

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Who knew a baby sock could cause such drama?

Production of the Owlet Smart Sock, a wearable monitor that can track a baby's sleep patterns and vital signs, has been halted after the U.S. Food and Drug Administration sent the company a warning letter, much to the anger of some parents.

Owlet Smart SocksPhoto credit: Bed Bath & Beyond

The FDA says that because the sock monitors a baby's heart rate and oxygen levels, it is a medical device that is being sold without proper "marketing approval, clearance, or authorization."

Related: One Manufacturer is Recalling its Coronavirus Home Test Kits — Again

The sock is now unavailable on Owlet's website, which states: "The Smart Sock is no longer available for sale in the U.S. as a consumer device. Owlet remains committed to empowering parents to provide better care at home. As such, we are actively pursuing submitting a medical device application to the FDA to bring the Smart Sock technology to medical and consumer markets in the future."

Plenty of parents are unhappy with the FDA's decision. A petition demanding that the FDA allow the sock back on the market has already received more than 125,000 signatures. Fans of the sock say it offers peace of mind. "Lost a son because we didn't have anything like this!" wrote one signer. "I would hate for anyone else to have to go through that and feel that pain."

Owlet says it has sold 1 million Smart Socks. But despite their popularity, the Smart Sock and other wearable monitors have stirred controversy in the past. Medical experts say they often malfunction and cause unnecessary anxiety. A class-action lawsuit over false alarms was filed in 2019 and dismissed in 2020. 

Related: Potentially Dangerous Baby Products to Watch Out For

The controversy over the Owlet is the latest to befall a popular baby product. While the Owlet hasn't been recalled or linked to safety issues, the Boppy Company recalled 3 million infant loungers earlier this year after they were linked to the suffocation deaths of eight babies. In an even bigger recall, the enormously popular Fisher-Price Rock 'n Play was pulled in 2019 and has been linked to more than 50 deaths. 

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