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CLASS II · ModerateFDA

Happiest Baby, Inc recalls Happiest Baby

📅 Aug 7, 2026 · 📍 Nationwide
Recalling company
Happiest Baby, Inc
Product
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Reason
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Aug 7, 2026
Reported
Sep 23, 2026
Distribution
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.
Status
Ongoing
Quantity
1055 units
Lot / codes
All Lots/UDI: None
Company location
Los Angeles, CA
Recall type
Voluntary: Firm initiated
Recall number
Z-3175-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3175-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.