The recall is limited exclusively to the XS and XL versions of the SNOO Sack. The company’s flagship SNOO Smart Sleeper, along with its small, medium, and large swaddle sizes, remain unaffected as they received FDA De Novo authorization in 2023. Sleepea swaddles, which are not designed for use with the SNOO bed, are also excluded from the action.
Happiest Baby Recalls XS and XL SNOO Sacks Over Regulatory Gaps
Parents are being urged to stop using and discard extra-small and extra-large SNOO Sacks following a regulatory review by the U.S. Food and Drug Administration. The agency determined these specific sizes were marketed without the necessary premarket authorization required for the company’s smart sleeper accessories.
Regulators flagged the sizes because their dimensions—the XS is smaller than the authorized small, while the XL is larger than the authorized large—could lead to an improper fit for infants. While Happiest Baby reports no injuries linked to the products, the company is offering refunds or exchanges for affected customers. Those who purchased units through the official website can process claims online, while Amazon customers are directed to contact the retailer directly for support.
Comments (0)
No comments yet. Be the first!