FDA-Device2026-09-23Class IIMISBRANDING
Happiest Baby SNOO Sleep Sack extra-small and extra-large sizes recalled for lack of FDA safety review
What this means
Happiest Baby, Inc. is recalling certain SNOO Sleep Sack sizes (extra-small and extra-large) because these sizes were not reviewed by the FDA for safety and effectiveness before being sold. The smaller and larger sizes do not have the same regulatory clearance as other sizes.
- Check if you have an extra-small (ES) or extra-large (XL) SNOO Sleep Sack by looking at the model number on the product tag.
- Stop using the sleep sack if you have one of the affected sizes.
- Contact Happiest Baby for a refund or replacement in an approved size.
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
14837
Manufactured in
11390 W Olympic Blvd Ste 450, N/A, Los Angeles, CA, United States
Products
Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534 S2101-535 S2101-536 S2101-541 S2101-551 S2102-508-10 S2102-508-9 S2103-501 S2103-502 S2103-504 S2103-508-11 S2103-508-12 S2103-508-13 S2103-508-14 S2103-508-6 S2103-508-7 S2103-508-8
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3176-2026More Happiest Baby recalls
- FDA-Device2026-09-23Happiest Baby SNOO Sleep Sack X-Small and X-Large sizes lack FDA safety review
Want 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.