Happiest Baby SNOO Sleep Sacks
Extra small and extra large SNOO Sleep Sacks have not been reviewed for safety and effectiveness by the FDA.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Happiest Baby, Inc. of Los Angeles, California, recalled its SNOO Sleep Sack in X-Small and X-Large sizes because the extra small and extra large infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. The recall began on August 7, 2026, and was added to the FDA's Enforcement Report on September 15, 2026, with distribution nationwide across the United States.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/
- Catalog code
- 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
- Lot
- All Lots/ No UDI
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/
- Catalog code
- S2101-101
- S2101-108-6
- S2101-133
- S2102-112
- S2107-101
- S2107-110
- Lot
- All Lots/UDI: None
Details
- Company began the recall
- Sold in
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.
- Event ID
- 99608
- Recall numbers
- Z-3175-2026 to Z-3176-2026
- Company
- Happiest Baby, IncLos Angeles, California
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
