Happiest Baby, the consumer baby-care company founded by pediatrician Harvey Karp, announced a voluntary recall this week of extra-small and extra-large SNOO Sack accessories following guidance from the U.S. Food and Drug Administration.
The company is asking customers to discontinue use and discard their XS and XL SNOO Sacks—soft fabric accessories designed to fit inside the SNOO Smart Sleeper, an FDA-authorized motorized bassinet. The recall does not affect the SNOO Smart Sleeper itself or the small, medium and large SNOO Sack sizes, which received FDA De Novo authorization in 2023.
According to Happiest Baby's statement, the XS and XL sizes were introduced after the original FDA submission was completed. The FDA determined that these two new sizes required their own premarket authorization before remaining on the market.
The XS SNOO Sack is three-quarters of an inch narrower and two inches shorter than the FDA-authorized small size. The XL version is half an inch wider and three inches longer than the large size. According to the FDA, these dimensional changes could result in a fit that is either too loose or too tight, creating a potential safety concern. Happiest Baby has not documented any injuries related to the use of these products.
Happiest Baby launched the two new product sizes without first securing FDA clearance for those specific variants, a regulatory gap that suggests either a misunderstanding of FDA requirements or a decision to move quickly to market.
This pattern is not uncommon in the medical device industry. Companies sometimes expand product lines based on market demand, then encounter regulatory pushback when the FDA determines that changes to dimensions, materials or intended use require formal review.
The SNOO Smart Sleeper has become popular among affluent parents since its launch. The device, which retails for several hundred dollars, uses gentle motion and white noise to soothe infants. Karp's parenting books and videos have built significant brand loyalty.
Customers who purchased XS or XL SNOO Sacks directly from Happiest Baby's website can apply for a refund or exchange for an authorized size through the company's support portal. Those who bought the XL version through Amazon are directed to contact the retailer.
No injuries have been reported in connection with these products, according to Happiest Baby.
