06/22/2026
On June 15, 2026, the FDA issued a formal Warning Letter to Happiest Baby, maker of the SNOO. They were selling new sleep sack sizes and the SNOO Hospital Bundle without FDA review or authorization. The FDA also points to mold reported on SNOO mattresses, stains, and unsanitary conditions on refurbished units sent to families.
Read the full article at: 🔗https://www.contemporarypediatrics.com/view/fda-issues-warning-letter-to-snoo-smart-sleeper-maker-over-unauthorized-sleep-sacks-hospital-bundle-and-quality-system-failures
If you own or are considering a SNOO:
1. STOP using unauthorized items
2. Inspect your unit
3. Report problems to the FDA
4. Talk to your pediatrician or a safe sleep educator for help with safe sleep practices