Happiest Baby SNOO Sleep Sack X-Small Models: FDA Safety Review Needed
Happiest Baby recalls X-Small SNOO Sleep Sacks (models S2101-101, S2101-108-6, etc.) due to lack of FDA safety review. Consumers should check model numbers and contact the company for details.
Recall notice
Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.
What happened, in plain English
Happiest Baby is recalling X-Small SNOO Sleep Sacks with specific model numbers because these products haven't been reviewed by the FDA for safety and effectiveness. This means parents should check their sleep sacks and contact the company if they have the recalled models. Read more at govinfonow.com/recall/1134615-happiest-baby-snoo-sleep-sack-x-small-models-fda-safety.
Source Summary by GovInfoNow · govinfonow.com/recall/1134615-happiest-baby-snoo-sleep-sack-x-small-models-fda-safety · Updated October 4, 2026 · FDA enforcement record: FDA #Z-3175-2026
Cite this page
“Happiest Baby SNOO Sleep Sack X-Small Models: FDA Safety Review Needed.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1134615-happiest-baby-snoo-sleep-sack-x-small-models-fda-safety. Based on FDA recall #Z-3175-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3175-2026%22&limit=1).
Why it’s dangerous
The FDA has not reviewed the safety and effectiveness of these extra small infant sleep sacks. This means there could be safety issues that weren't identified during the review process.
Who’s affected
Parents who own or use Happiest Baby SNOO Sleep Sacks with the listed model numbers are affected. Infants using these sleep sacks are at risk if the product hasn't been reviewed by the FDA.
How to tell if you have this one
Check the model numbers on your SNOO Sleep Sack: S2101-101, S2101-108-6, S2101-133, S2102-112, S2107-101, or S2107-110. The product was sold without FDA safety review.
- Brand
Happiest Baby- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3175-2026 | Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110; All Lots/UDI: None | 1055 units |
| Z-3176-2026 | Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512 S2101-513 S2101-532 S2101-533 S2101-534 S2101-535 S2101-536 S2101-541 S2101-551 S2102-508-10 S2102-508-9 S2103-501 S2103-502 S2103-504 S2103-508-11 S2103-508-12 S2103-508-13 S2103-508-14 S2103-508-6 S2103-508-7 S2103-508-8; All Lots/ No UDI | 14837 |
What to do — step by step
Check Model Numbers
Look for the model numbers S2101-101, S2101-108-6, S2101-133, S2102-112, S2107-101, or S2107-110 on the sleep sack.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 50 states.
FDA distribution: “US Nationwide distribution including in the states of Alabama, Alaska, ANONYMIZED, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3175-2026 (August 7, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3175-2026 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.