Official recall notice
FDA DeviceClass IINotable
FDA Recall: Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508
- Recall date
- 2026-09-23
- Brand
- Happiest Baby, Inc
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Product description
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Affected products
All Lots/ No UDI