Skip to content

Happiest Baby, Inc.

United Statesfrom the FDA registration address FDA FEI 3030187577

Devices
2
Registrations
FDA
FDA recalls
33 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue2

Newest first, rows 1-2 of 2

  • SNOO Smart Sleeper S1000

    None Registry: GUDID Class:II

  • SNOO Smart Sleeper Ref DEN210039

    Active Regimes: De Novo Registry: De Novo Class:II

Company details

FDA FEI number
3030187577
DUNS number
618462688
Address
11390 W Olympic Blvd., Los Angeles, CA, 90064
Phone
855-424-6323

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 1
  • 2025 0
  • 2026 2

  • 2026

    • 7 Aug 2026 Z-3175-2026 Class II Ongoing Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. Distribution: US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California,…
      Full distribution text US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
    • 7 Aug 2026 Z-3176-2026 Class II Ongoing Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. Distribution: US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California,…
      Full distribution text US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

  • 2024

    • 15 May 2024 Z-2882-2026 Class II Ongoing This recall is retroactively being reported. Due to complaints, refurbished baby sleep sacks failed to meet quality standards before distribution appearing to be uncleaned. Distribution: US Nationwide distribution in states of PA, WA, CA, NJ.

Frequently asked questions

How many devices does Happiest Baby, Inc. have in the registry?

The registry currently lists 2 devices for Happiest Baby, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Happiest Baby, Inc.'s devices?

Among its 2 most recently registered devices, Happiest Baby, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Happiest Baby, Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Happiest Baby, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Happiest Baby, Inc.?

FDA recall records list 3 recalls initiated by Happiest Baby, Inc., the most recent initiated on 7 Aug 2026. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Happiest Baby, Inc. in the registry?

The most recently registered devices listed for Happiest Baby, Inc. include SNOO Smart Sleeper S1000 and SNOO Smart Sleeper.

Generated automatically from registry data and not verified by a human reviewer.