Z-3176-2026Class II

Happiest Baby, Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Happiest Baby, Inc

Product type

Device

Status

Ongoing

Report date

2026-09-23

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.

Firm state

Product quantity

14837

Initiated by

Voluntary: Firm initiated

Reason for recall

Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

Product description

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

Code / lot info

All Lots/ No UDI

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →