FDA warns Happiest Baby over unauthorized SNOO sleep sacks and unsanitary units

On June 15, 2026, the U.S. Food and Drug Administration sent Happiest Baby a warning letter finding that its SNOO Smart Sleeper was sold with two sleep-sack sizes the agency had never authorized, one of which the FDA said could ride up and cover the infant's mouth or neck & cause respiratory compromise, suffocation, or death. The same letter documented families receiving moldy & soiled refurbished bassinets, complaints the company had closed as user error, & a required safety report the company never filed.

Background

Happiest Baby, Inc. makes the SNOO Smart Sleeper, a Wi-Fi-connected smart bassinet that rocks an infant & plays white noise. In 2023 the FDA authorized marketing of the SNOO as an over-the-counter infant sleep system. That clearance, a De Novo authorization numbered DEN210039, covered the bassinet together with the SNOO Sleep Sack for home use by caregivers of infants from birth to six months, with three sizes of sleep sack (small, medium, & large). The FDA inspected Happiest Baby's Los Angeles facility from July 21 to 25, 2025, & issued the warning letter after considering the company's responses of August 15, 2025 & February 26, 2026.

Unauthorized sleep sacks

The FDA wrote that the SNOO Smart Sleeper & a companion "SNOO Hospital Bundle" were adulterated & misbranded because Happiest Baby had made significant changes to the authorized device without submitting them for review. Two of the changes were sleep-sack sizes outside the three the agency had cleared.

The company had begun selling an extra-small sack marketed for infants as light as four pounds, a range that includes more preterm infants. The FDA wrote that the smaller sack could be too tight & could compress vital organs, limit diaphragmatic movement, and result in respiratory compromise, & that reaching lower birth weights raised the device's risk profile because preterm infants face a higher risk of SIDS. An extra-large sack marketed for infants of 23 to 25 pounds could, the agency wrote, ride up and cover the infant's mouth or neck & cause respiratory compromise, suffocation, or death, or let a smaller infant break free into an unsafe position.

The FDA also faulted the company for marketing the home-use bassinet to hospitals as the SNOO Hospital Bundle, including for use in neonatal intensive care, though the authorization covered only home use. The bundle added a wheeled mobility cart that the agency said introduced tipping & rolling risks the original authorization never evaluated.

Sanitation and quality-system failures

The inspection found that Happiest Baby grouped unrelated complaints together, limiting the investigation of each one; the FDA reviewed 17 complaints & found 9 handled this way. One grouped record, opened in April 2023, covered customer reports of mold on SNOO mattresses & covers months into use, which the company concluded were user error even after customers said they had followed the cleaning instructions.

A separate record from May 2024 covered four complaints of dirty, stained, & soiled bassinets, all of which the company traced to its refurbisher; an inspection of the refurbished units found that every sampled unit failed the company's own quality standards. The FDA wrote that unsanitary bassinets can expose infants, whose immune systems are still developing, to contaminated surfaces & pathogens. Consumer Reports noted that Happiest Baby sells refurbished pre-loved SNOOs directly to parents at a discount.

Investigators also flagged a complaint in which a parent reported that a SNOO sleep sack was riding up and seem[s] like it is choking baby; the company grouped it with others, performed one report determination for the batch, & concluded it was not reportable. The agency separately found that the company's design validation used an average-size model infant rather than testing across the authorized five-to-twenty-five-pound range.

FDA response and company statement

The FDA wrote that the company had also failed to file a required Report of Correction or Removal after it sent replacement bassinets to customers who returned unsanitary units, & that as of June 11, 2026 no such report had been submitted. The letter warned that continued violations could bring seizure, injunction, or civil money penalties.

Consumer Reports, which reported the letter on June 16, 2026, noted that the FDA did not say that any babies had been injured by the SNOO. Happiest Baby told the magazine that parents using its small, medium, & large sacks could continue to use them safely and with confidence, that it was committed to addressing the FDA's questions about the extra sizes, & that it had ended its relationship with one refurbisher two years earlier.