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U.S. Department of Health and Human Services

Class 2 Device Recall Happiest Baby, Inc SNOO Sleep Sack, XSmall

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 Class 2 Device Recall Happiest Baby, Inc SNOO Sleep Sack, XSmallsee related information
Date Initiated by FirmAugust 07, 2026
Date PostedSeptember 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3175-2026
Recall Event ID 99608
Product Classification Infant supine sleep system - Product Code QTG
ProductHappiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Code Information All Lots/UDI: None
FEI Number 3030187577
Recalling Firm/
Manufacturer		 Happiest Baby, Inc
11390 W Olympic Blvd Ste 450
Los Angeles CA 90064-1607
For Additional Information ContactCustomer Care
310-4764440
Manufacturer 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 Determined
Cause 2		Device Design
ActionOn 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 Commerce1055 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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