Happiest Baby SNOO Sleep Sack Recall for FDA Review Status
Happiest Baby, Inc is recalling 1,055 units of SNOO Sleep Sacks because Extra Small and Extra Large sizes 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 is classified as FDA Class II, and the source text explicitly states the products have not been reviewed for safety and effectiveness, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Happiest Baby, Inc is recalling 1,055 units of SNOO Sleep Sacks, specifically the X-Small size, due to regulatory review status. The recall notice states that Extra Small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
The affected products are distributed nationwide across the United States, including all 50 states, the District of Columbia, and Puerto Rico. The specific model and catalog numbers involved are S2101-101, S2101-108-6, S2101-133, S2102-112, S2107-101, and S2107-110.
Consumers who have purchased these specific units should stop using them and contact the recalling firm for instructions on how to proceed. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
- Manufacturer
- Happiest Baby, Inc
- Hazard
- Affected units
- 1,055
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/UDI: None
Distribution
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