Tag: warning_letter

FDA Issues Warning to SNOO Smart Sleeper Manufacturer Over Unauthorized Products and Unsanitary Conditions

15 Jun 2026 6:51 p.m. · Source: US Food and Drug Administration

The FDA has warned Happiest Baby, Inc., maker of SNOO Smart Sleeper, for selling unauthorized sleep sacks and hospital bundles, and for unsanitary refurbished units and mold reports, urging caution for users.

Health Politics and Government Business Medical Science Federal Government Legal Social Issues Education FDA SNOO Smart Sleeper Happiest Baby, Inc.Warning Letter Medical Devices Product Safety Infant Care Food Recalls Drugs