Recall Z-3175-2026— Happiest Baby, Inc
Class II · Ongoing
Class II FDA medical device recall by Happiest Baby, Inc, initiated 2026-08-07. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA..
- Recalling firm
- Happiest Baby, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-07
- Firm location
- Los Angeles, CA, United States
Product description
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Reason for recall
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Data sourced from openFDA. This site is unofficial and independent of the FDA.