Recall Z-3176-2026
Happiest Baby, Inc · initiated August 7, 2026
Product
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
Codes / lots: All Lots/ No UDI
Reason for recall
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
FDA-determined cause: Device Design
Action taken
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).
Details
- Recall number
- Z-3176-2026
- Initiated
- August 7, 2026
- Posted by FDA
- September 15, 2026
- Product code
- QTG – Infant Supine Sleep System
- Quantity
- 14837
- 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…
- Recalling firm
- Happiest Baby, Inc, Los Angeles, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3175-2026 | Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6…Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness… | 08/07/2026Open, Classified |