Recall Z-3175-2026 ยท QTG Infant Supine Sleep System
Happiest Baby, Inc
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
| Date | Sep 15, 2026 (initiated Aug 7, 2026) |
| Status | Open, Classified |
| Reason | Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. |
| Root cause | Device Design |
| Action | On August 7, 2026, Happiest Baby, Inc. issued a Urgent Medical Device Recall notification to affected consignees via email. Happies Baby, asked consingees to take the following actions: 1. Please discontinue use of your XS SNOO Sack(s) and XL SNOO Sack(s) and discard it. (If you gave anyone an XS SNOO Sack and/or XL SNOO Sack, please share this letter to inform them of these important recall instructions.) 2. If you purchased an XS SNOO Sack and/or XL SNOO Sack in the U.S., directly from Happiest Baby, and would like a refund or exchange for a small, medium, or large SNOO Sack, please vi |
| Quantity | 1055 units |
| Distribution | US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.