RegWardenFDA facility compliance records
Facility

HAPPIEST BABY, INC.

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2024: 1 recalls; 2025: 1 inspections; 2026: 1 recalls, 1 warning letters2017201820192020202120222023120241202522026
  • Recalls (2)
  • Inspections (1)
  • Warning letters (1)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2026-08-07
    Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
  • Class IIOngoing2024-05-15
    This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.

FDA inspections (1)

  • OAI2025-07-25
    Official 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)

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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