FDA warns Happiest Baby over new SNOO sleep-sack sizes and facility conditions
@CBSNews reported that the FDA issued a warning letter to Happiest Baby, Inc. for selling unapproved extra-small and extra-large sleep sacks and for unsanitary manufacturing conditions on the $1,700 SNOO bassinet.
fda.govS. , maker of the SNOO Smart Sleeper bassinet, after determining the company introduced two new sizes of sleep sacks without prior agency review. The letter states there is evidence that the firm changed or modified the SNOO Smart Sleeper by introducing extra-small and extra-large sleep sacks.
These sizes have not been evaluated for safety and effectiveness by the FDA. Inspectors also cited stains, soiling and unsanitary conditions that may pose a risk of infection, as well as mold found on some SNOO smart sleeper mattresses and mattress covers. The SNOO bassinet is priced at $1,700.
Babies are clipped into a sleep sack that attaches to the sides of the device, which automatically rocks infants when they cry. Happiest Baby, Inc. stated it is committed to working with the FDA to address the matters in the letter.
The company said it ended a relationship two years ago with one of its refurbishing partners after determining the partner was not properly cleaning the products. A. was issued on May 27, 2026, under reference 320-26-80.
Kelsie Hoffman contributed to the CBS News report.
