Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/ recall: Extra small (ES) and Extra-large (XL) infant sleep sacks have
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-3175-2026
- Published
- September 23, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Happiest Baby, Inc
- Product type
- Medical devices
- Units affected
- 1055 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- All Lots/UDI: None
Products covered by this recall
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Check your product
The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- UDI
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Happiest Baby, Inc — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Report device problems to the FDA through MedWatch.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
- Ask the supplier or clinic that provided it what the remedy is in your case.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: Happiest Baby, Inc — 11390 W Olympic Blvd Ste 450, Los Angeles, CA, 90064-1607
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Happiest Baby, Inc medical devices recalled?
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: lot code UDI. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
Where was the recalled product sold?
It was distributed nationwide.
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