Happiest Baby, Inc recalls Happiest Baby
Reason for recall
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S10004 affected lots9677201861339395302320171272281787142127000400400069193417621270
What the firm is doing
Happiest Baby, Inc. did not issue a formal communication. Between the dates of May and July 2024, customers that noted issues with the product returned the affected unit and were provided a replacement.
DistributionShow detailsHide
US Nationwide distribution in states of PA, WA, CA, NJ.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2882-2026
- FDA device classification · QTGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5690The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Happiest Baby, IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
More Class II recalls
Contego Medical, Inc recalls Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Em…
Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may fail to open following sheath retraction;…
- Carotid Stent
- Process control
Freudenberg Medical, LLC recalls Blom-Singer Classic Indwelling Voice Prosthesis
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
- Laryngeal (Taub) Prosthesis
- Labeling mix-ups
Freudenberg Medical, LLC recalls Blom-Singer Classic Indwelling Voice Prosthesis
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.
- Laryngeal (Taub) Prosthesis
- Labeling mix-ups
