LOS ANGELES, Aug. 7, 2026 /PRNewswire/ — Today, Happiest Baby announced a voluntary recall of its extra-small (XS) and extra-large (XL) SNOO Sacks®. This action follows a communication from the U.S. Food and Drug Administration (FDA), advising Happiest Baby that the Company needed to obtain FDA’s premarket authorization for those two sizes.
Out of an abundance of caution, customers are asked to discontinue use and discard their XS and XL SNOO Sacks.
This recall does not include the SNOO Smart Sleeper or the small, medium, and large SNOO Sacks. SNOO Smart Sleeper® and the small, medium, and large SNOO Sacks received FDA
De Novo authorization in 2023. In addition, it does not affect any Sleepea® swaddle sacks, including XS and XL Sleepeas. (Sleepea sacks have no wings and are only designed for use outside of a SNOO.)
The XS and XL SNOO Sacks were launched after the original FDA De Novo submission and, as a result, were not part of the FDA review.
Note: The XS SNOO Sack is ¾” narrower and 2″ shorter than the FDA-authorized small size sack. The XL SNOO Sack is ½” wider and 3″ longer than the FDA-authorized large size sack. The FDA stated that these changes could result in a fit that was too loose or too tight. Happiest Baby has not received any reports of injury in connection with the use of XS or XL SNOO Sacks.
Anyone who purchased an XS or XL SNOO Sack, in the U.S. from Happiest Baby’s website can apply for a refund or exchange for a small, medium, or large SNOO Sack by visiting http://happiestbaby.com/xs-xl-support. Customers who purchased an XL SNOO Sack from Amazon should contact Amazon directly (888-280-4331).
Happiest Baby remains committed to meeting the highest standards for quality, safety, and family wellbeing. SNOO remains the first and only baby bed granted FDA De Novo authorization for keeping babies safely positioned on the back—all naps, all night.
Consumers with further questions are encouraged to contact Happiest Baby Customer Care at http://happiestbaby.com/help.
ABOUT HAPPIEST BABY
Happiest Baby, Inc. is a mission-driven company dedicated to enhancing the health and well-being of children, parents, and healthcare workers. Co-founded by world-renowned pediatrician Dr. Harvey Karp and his wife, Nina Montée Karp, the company creates innovative, science-backed content and products such as the SNOO Smart Sleeper, Sleepea swaddle, and the SNOObie white noise machine.
Dr. Karp is the author of the celebrated parenting books and videos, The Happiest Baby on the Block, The Happiest Toddler on the Block, The Happiest Baby’s Guide to Great Sleep: Birth to Five. They have been translated into dozens of languages and helped millions of families worldwide.
CONTACT
press@happiestbaby.com
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SOURCE Happiest Baby, Inc.
