Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2882-2026Class II

Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000

Happiest Baby, Inc / initiated 2024-05-15 / Open, Classified

Happiest Baby, Inc began a recall of Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000 on . FDA classified it as Class II and gives the reason as "This recall is retroactively being reported. Due to complaints, refurbished baby sleep sacks failed to meet quality standards before distribution appearing to be uncleaned". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2882-2026
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Happiest Baby, Inc
Product
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
Product code
QTG Infant Supine Sleep System
Reason for recall
This recall is retroactively being reported. Due to complaints, refurbished baby sleep sacks failed to meet quality standards before distribution appearing to be uncleaned.
FDA root cause
Reprocessing Controls
Action
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.
Quantity in commerce
4 units
Distribution
US Nationwide distribution in states of PA, WA, CA, NJ.
Product codes and lots
Lot Code: 9677201861339395 3023201712722817 8714212700040040 0069193417621270

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2882-2026
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2882-2026Class IIOngoingVoluntary: Firm initiated