{"recall":{"id":"fda-device-99608","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":true,"kind":"device","title":"Happiest Baby, Inc recalls 2 products","firm":"Happiest Baby, Inc","date":"2026-08-07","reported":"2026-09-23","status":"Ongoing","classification":"Class II","products":[{"name":"Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110","code":"All Lots/UDI: None","quantity":"1055 units","number":"Z-3175-2026","classification":"Class II"},{"name":"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","code":"All Lots/ No UDI","quantity":"14837","number":"Z-3176-2026","classification":"Class II"}],"reason":"Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"1055 units; 14837","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99608","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7bd968796b764468","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99608","record":[{"status":"Ongoing","city":"Los Angeles","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99608","recalling_firm":"Happiest Baby, Inc","address_1":"11390 W Olympic Blvd Ste 450","address_2":"N/A","postal_code":"90064-1607","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"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":"Z-3175-2026","product_description":"Happiest Baby, Inc SNOO Sleep Sack, X-Small   Model/Catalog Number: S2101-101\tS2101-108-6\tS2101-133\tS2102-112\tS2107-101\tS2107-110","product_quantity":"1055 units","reason_for_recall":"Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.","recall_initiation_date":"20260807","center_classification_date":"20260915","report_date":"20260923","code_info":"All Lots/UDI: None","more_code_info":""},{"status":"Ongoing","city":"Los Angeles","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99608","recalling_firm":"Happiest Baby, Inc","address_1":"11390 W Olympic Blvd Ste 450","address_2":"N/A","postal_code":"90064-1607","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"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":"Z-3176-2026","product_description":"Happiest Baby, Inc. SNOO Sleep Sack, X-Large  Model/Catalog Number: S2101-501\tS2101-508-11\tS2101-508-3\tS2101-508-4\tS2101-508-5\tS2101-508-6\tS2101-508-7\tS2101-512\tS2101-513\tS2101-532\tS2101-533\tS2101-534\tS2101-535\tS2101-536\tS2101-541\tS2101-551\tS2102-508-10\tS2102-508-9\tS2103-501\tS2103-502\tS2103-504\tS2103-508-11\tS2103-508-12\tS2103-508-13\tS2103-508-14\tS2103-508-6\tS2103-508-7\tS2103-508-8","product_quantity":"14837","reason_for_recall":"Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA.","recall_initiation_date":"20260807","center_classification_date":"20260915","report_date":"20260923","code_info":"All Lots/ No UDI","more_code_info":""}]}}