Infant Supine Sleep System
FDA product code QTG · Class II (moderate risk) · 21 CFR 880.5690 · General Hospital
An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).
0510(k) clearances
0PMA approvals
3recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3176-2026 | Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501…Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness… | Happiest Baby, Inc | 08/07/2026Open, Classified |
| 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… | Happiest Baby, Inc | 08/07/2026Open, Classified |
| Z-2882-2026 Class II | Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000This recall is retroactively being reported. Due to complaints, refurbished baby sleep sacks failed to meet… | Happiest Baby, Inc | 05/15/2024Open, Classified |