HAPPIEST BABY, INC.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (1)
- Warning letters (1)
Devices registered here (1)
- Infant Supine Sleep SystemProduct code QTG (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5690
Recalls & enforcement
- Class IIOngoing2026-08-07Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
- Class IIOngoing2024-05-15This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
FDA inspections (1)
- OAI2025-07-25Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
FDA warning letters (1)
- Warning Letter2026-06-15Warning Letter (opens in a new tab) · Los Angeles California
Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “HAPPIEST BABY, INC. (FEI 3030187577) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3030187577-happiest-baby-inc/
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