Device recalls

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, ClassifiedDevice DesignZ-3175-2026
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
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.