FDAClass II · Medical device · Recall Z-3176-2026 · Recalled September 23, 2026

Happiest Baby recall — Happiest Baby, Inc

Agency report date: September 23, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Happiest Baby
Company / brand: Happiest Baby
Lot / serial / date codes: All Lots/ No UDI
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.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Happiest Baby recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-3176-2026
Brand: All Happiest Baby recalls
Classification: Class II
Units affected: 14,837
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Happiest Baby recall status

Companies & origin

Recalling firm location: Los Angeles, CA, United States
Firm address: 11390 W Olympic Blvd Ste 450, N/A, 90064-1607

Identifying details (verbatim from the notice)

Product codes / lots: All Lots/ No UDI
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.
Firm notified the public via: E-Mail
FDA event ID: 99608
Recall initiated: August 7, 2026
FDA classified: September 15, 2026
FDA report date: September 23, 2026

Other medical device recalls from around the same time

INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recall — CooperSurgical, Inc.FDA · September 30, 2026
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP recall — CooperSurgical, Inc.FDA · September 30, 2026
Haylard UNIV IMAGING BIOPSY TRUCUSTOM recall — AVID Medical, Inc.FDA · September 23, 2026
Haylard BASIC BIOPSY TRAY recall — AVID Medical, Inc.FDA · September 23, 2026
Haylard CONTINUOUS NERVE BLOCK TRAY recall — AVID Medical, Inc.FDA · September 23, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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