06/16/2026
We're not affiliated with Snoo either way but it's important to note that the FDA letter doesn't allege that any harm came to babies. It does provide warnings to prevent potential harm in the future. The letter says:
- Snoo added an XS and XL size sleep sacs without FDA clearance. This means the sacs can present a potential breathing risk or ride-up on babies' faces. Snoo responded, but responses were rejected because Snoo argued that testing didn't need to be done on the new sizes.
- It's being marketed to hospitals/NICUs when they are only cleared for home use. The environments are different and the addition of the wheeled "mobility cart" was never evaluated by FDA. The cart is a potential tip/roll risk.
- Refurbished bassinets sold by Snoo reportedly received dirty/soiled. Company cleaned those units and has halted shipments from its refurbisher.
Important update for SNOO Smart Sleeper users:
If you have, or are considering purchasing a SNOO Smart Sleeper, please be aware that its manufacturer, Happiest Baby, Inc., has been selling new sleep sack sizes and hospital SNOO bassinet bundles without first undergoing FDA review and obtaining FDA authorization.
The FDA strongly cautions patients, caregivers and health care providers that the X-Small and X-Large sleep sacks, and the SNOO Hospital Bundle, have not been evaluated for safety and effectiveness by the FDA and pose increased risks as described in the Warning Letter. The FDA also cautions that stains, soiling and unsanitary conditions have been reported on refurbished SNOOs distributed to customers, which may pose risk of infection. The FDA also cautions that mold has been reported on SNOO Smart Sleeper mattresses and/or mattress covers. Users should report any problems with SNOO products through the MedWatch Voluntary Reporting Form.
https://www.fda.gov/medical-devices/products-and-medical-procedures/pediatric-medical-devices
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
