| | Class 2 Device Recall Happiest Baby, Inc Preloved SNOO Smart Sleeper |  |
| Date Initiated by Firm | May 15, 2024 |
| Date Posted | August 04, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2882-2026 |
| Recall Event ID |
99365 |
| Product Classification |
Infant supine sleep system - Product Code QTG
|
| Product | Happiest Baby, Inc
Pre-loved SNOO Smart Sleeper
Model:S1000 |
| Code Information |
Lot Code: 9677201861339395
3023201712722817
8714212700040040
0069193417621270
|
| FEI Number |
3030187577
|
Recalling Firm/ Manufacturer |
Happiest Baby, Inc 11390 W Olympic Blvd Ste 450 Los Angeles CA 90064-1607
|
| For Additional Information Contact | Customer Care 310-4764440 |
Manufacturer 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 Determined Cause 2 | 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. |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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