Device recall
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
- Recall number
- Z-3176-2026
- Event id
- 99608
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Happiest Baby, Inc
- Report date
- Sep 23, 2026
- Posted
- Sep 15, 2026
- Initiated
- Aug 7, 2026
- Center classification date
- Sep 15, 2026
- Product code
- QTG
- Device type
- Infant Supine Sleep System
- Reason
- Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
- Root cause
- Device Design
- Quantity
- 14837
- Code info
- All Lots/ No UDI
- 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.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Los Angeles, CA, United States