Happiest Baby, Inc recalls Happiest Baby, Inc SNOO Sleep Sack, X-Small and 1 other product
Happiest Baby, Inc recalled Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110 and 1 other product beginning August 07, 2026, in a medical device recall whose distribution included Ohio. FDA assigned 2 recall numbers to the action, one per product; all of them are listed with this filing. The stated reason: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. FDA graded it Class II — use may cause temporary or medically reversible health consequences. Quantity affected: 1055 units. The recall is listed as ongoing.
Writing the report from the record…
The source filing
| Recall number | Z-3175-2026 |
|---|---|
| Recalls in this action | 2 |
| Recalling firm | Happiest Baby, Inc |
| Product | Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110 |
| Reason for recall | Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. |
| Classification | Class II — use may cause temporary or medically reversible health consequences |
| Recall type | medical device |
| Quantity | 1055 units |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm initiated |
| Initiated | 20260807 |
| Reported | 20260923 |
| 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, Ne |
| Firm location | Los Angeles, CA, United States |
Published by U.S. Food and Drug Administration (openFDA). This is the agency's public filing as The Lantern received it, shown with its fields named in plain English.