Z-3176-2026Class II

Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3...

Name: Z-3176-2026 Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3...
Creator: Happiest Baby, Inc
Published: 2026-08-07
License: https://open.fda.gov/license/

Happiest Baby, Inc / initiated 2026-08-07 / Open, Classified

FDA source

Recall record

Recall number: Z-3176-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-07
Posted: 2026-09-15
Recalling firm: Happiest Baby, Inc
Product: Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534 S2101-535 S2101-536 S2101-541 S2101-551 S2102-508-10 S2102-508-9 S2103-501 S2103-502 S2103-504 S2103-508-11 S2103-508-12 S2103-508-13 S2103-508-14 S2103-508-6 S2103-508-7 S2103-508-8
Product code: QTG Infant Supine Sleep System
Reason for recall: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
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 in commerce: 14837
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.
Product codes and lots: All Lots/ No UDI

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3176-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3175-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-15
Z-3176-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-15

Product code QTG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)