FDA Medical Device Recalls (openFDA)
Happiest Baby, Inc: Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
- Recall number
- Z-3175-2026
- Recalling firm
- Happiest Baby, Inc
- Product
- Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
- Status
- Open, Classified
- Initiated
- 2026-08-07
- Posted
- 2026-09-15
- Terminated
- not on file
- Reason
- Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
- Root cause
- Device Design
- Action
- On August 7, 2026, Happiest Baby, Inc. issued a Urgent Medical Device Recall notification to affected consignees via email. Happies Baby, asked consingees to take the following actions: 1. Please discontinue use of your XS SNOO Sack(s) and XL SNOO Sack(s) and discard it. (If you gave anyone an XS SNOO Sack and/or XL SNOO Sack, please share this letter to inform them of these important recall instructions.) 2. If you purchased an XS SNOO Sack and/or XL SNOO Sack in the U.S., directly from Happiest Baby, and would like a refund or exchange for a small, medium, or large SNOO Sack, please visit https://www.happiestbaby.com/xs-xlsupport for further instructions. 3. If you purchased an XS SNOO Sack and/or XL SNOO Sack through Amazon, please contact Amazon directly for next steps (888-280-4331).
- Quantity
- 1055 units
- Distribution
- 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.
- Lot, serial or model codes
- All Lots/UDI: None
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- QTG
- Firm FEI
- 3030187577
- Firm city
- Los Angeles
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28