Happiest Baby SNOO Sleep Sacks Recalled for Lack of FDA Review
Happiest Baby, Inc. is recalling SNOO Sleep Sacks because they have not been reviewed for safety and effectiveness by the FDA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infant sleep sack) where the hazard is the lack of FDA safety review, and no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Happiest Baby, Inc. is recalling SNOO Sleep Sacks in Extra Small (ES) and Extra Large (XL) sizes. The recall is being conducted because these infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
The affected products include specific model and catalog numbers, such as S2101-501 and S2103-508-8. The recall covers 14,837 units that were distributed nationwide across the United States, including all 50 states and the District of Columbia.
Consumers should stop using the recalled sleep sacks immediately. The FDA has not reviewed these specific products for safety and effectiveness, meaning they have not been cleared for use as medical devices.
The recalled product
- 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…
- Manufacturer
- Happiest Baby, Inc
- Hazard
- Affected units
- 14,837
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/ No UDI
Distribution
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