Device recall
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
- Recall number
- Z-3175-2026
- 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
- 1055 units
- Code info
- All Lots/UDI: None
- 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