Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Happiest Baby, Inc · Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Open FDA's page for this record- Cfres ID
- 221983
- Product res number
- Z-3175-2026
- Event date initiated
- 2026-08-07
- Event date posted
- 2026-09-15
- Recall status
- Open, Classified
- Res event number
- 99608
- Product code
- QTG
- Product description
- Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
- Code info
- All Lots/UDI: None
- Firm FEI number
- 3030187577
- Recalling firm
- Happiest Baby, Inc
- Address 1
- 11390 W Olympic Blvd Ste 450 11390 W Olympic Blvd
- Address 2
- Ste 450
- City
- Los Angeles
- State
- CA
- Postal code
- 90064-1607
- Additional info contact
- Customer Care 310-4764440
- Reason for recall
- Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
- Root cause description
- Device Design
- Product quantity
- 1055 units
- Action
On August 7, 2026, Happiest Baby, Inc. issued a Urgent Medical Device Recall notification to affected consignees via email. Happies Baby, asked consingees to take the following actions: 1. Please discontinue use of your XS SNOO Sack(s) and XL SNOO Sack(s) and discard it. (If you gave anyone an XS SNOO Sack and/or XL SNOO Sack, please share this letter to inform them of these important recall instructions.) 2. If you purchased an XS SNOO Sack and/or XL SNOO Sack in the U.S., directly from Happiest Baby, and would like a refund or exchange for a small, medium, or large SNOO Sack, please visit https://www.happiestbaby.com/xs-xlsupport for further instructions. 3. If you purchased an XS SNOO Sack and/or XL SNOO Sack through Amazon, please contact Amazon directly for next steps (888-280-4331).
- Distribution pattern
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.
- Harmonized identifiers (openFDA)
- Device name
- Infant Supine Sleep System
- Medical specialty description
- General Hospital
- Regulation number
- 880.5690
- Device class
- 2
- K number
- DEN210039
- Registration number
- 3013375997, 3030187577, 1531264, 3012497791
- FEI number
- 3013375997, 3030187577, 3002865632, 3012497791
