Happiest Baby, Inc
FDA Regulatory Profile
Happiest Baby, Inc appears in FDA public data with 3 recalls, 1 510(k) clearance, 1 FDA inspection, and 1 compliance action on record. Its most recent recall (Z-3175-2026, Class II) was initiated on August 7, 2026. Its most recent 510(k) clearance was granted on March 30, 2023.
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3175-2026 | Class II | Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 | August 7, 2026 |
| Z-3176-2026 | Class II | Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508 | August 7, 2026 |
| Z-2882-2026 | Class II | Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000 | May 15, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| DEN210039 | SNOO Smart Sleeper | March 30, 2023 |