FDA-Device2026-09-23Class IIMISBRANDING
Happiest Baby SNOO Sleep Sack X-Small and X-Large sizes lack FDA safety review
What this means
Happiest Baby has distributed extra-small and extra-large sizes of the SNOO Sleep Sack without FDA safety and effectiveness review. These sizes were not cleared through the required regulatory process before being sold.
- Check if you own an X-Small or X-Large SNOO Sleep Sack (models S2101-101, S2101-108-6, S2101-133, S2102-112, S2107-101, S2107-110)
- Contact Happiest Baby, Inc for instructions on next steps
- Do not use the product until you receive guidance from the manufacturer
The agency's original wording
Hazard
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Intended for
Infants (under 12 months)
Illnesses reported
None reported
Sold states
US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Affected count
1055 units
Manufactured in
11390 W Olympic Blvd Ste 450, N/A, Los Angeles, CA, United States
Products
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3175-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.