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SNOO Smart Sleeper
Happiest Baby, Inc. · Model S1000 · UDI-DI 00817720020085
1
510(k) clearances
11
Adverse events
3
Recalls
4
Facilities
Description
The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep. Infants who are placed in a supine sleep position are at lower risk of SIDS/SUID. The device is intended for home use by caregivers of infants from birth to 6 months of age, who are not yet able to roll over consistently.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-08-07 | Happiest Baby, Inc | Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. |
| 2026-08-07 | Happiest Baby, Inc | Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. |
| 2024-05-15 | Happiest Baby, Inc | This recall is retroactively being reported. Due to complaints, refurbished baby sleep sacks failed to meet quality standards before distribution appearing to be uncleaned. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.