{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218684", "product_res_number": "Z-1580-2026", "event_date_initiated": "2026-02-18", "event_date_posted": "2026-03-19", "recall_status": "Open, Classified", "res_event_number": "98426", "product_code": "FMS", "product_description": "Cub Pediatric Crib, Model FL19H", "code_info": "UDI-DI (GTIN)\n07613327169348\n\nSerial 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"firm_fei_number": "1831750", "recalling_firm": "Stryker Medical Division of Stryker Corporation", "address_1": "3800 E Centre Ave", "city": "Portage", "state": "MI", "postal_code": "49002-5826", "reason_for_recall": "Cribs sold in the USA are missing two access door warning labels.", "root_cause_description": "Under Investigation by firm", "action": "On February 18. 2026, the firm notified customers through IMPORTANT MEDICAL DEVICE CORRECTION letters. Customers were notified of the missing warning labels, which read, \n\n\"WARNING: Never leave a child unsupervised when the movable slide is open or not secured\nRefer to Instructions for Use for product care, maintenance, and cleaning.\"\n\nCustomers were instructed to locate the units listed on the attached business reply form and identify the address where they can be serviced, and return the completed form to Stryker. Stryker will then contact consignees to arrange for the application of the missing label.\n\nIn the interim, until the service can be performed, all pertinent warnings and\nsafety instructions may be found in the product manual: https://techweb.stryker.com/Stretcher/FL19/1607/Operations/1900-109-\n001AC.0.pdf", "product_quantity": "590", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K845002", "K950058", "K852173", "K852422", "K951024", "K881019", "K960012", "K963210", "K925949", "K810728", "K821773", "K880838", "K900873", "K950059", "K845003", "K853355", "K960747", "K925817", "K925530", "K970334", "K860120", "K901763", "K883818", "K950051", "K860596", "K921327", "K845004" ], "registration_number": [ "3008058231", "3033433849", "9681454", "3030516433", "3026311463", "3008881803", "3006513362", "1317511", "1831750", "3011719874", "3030019986", "3008791302", "3009162879", "1318843", "3003600763", "3006802326", "3006891315", "3017181414", "3011659880", "1043568", "9613910", "3003749961", "3006795806", "3015286905", "3005706637" ], "fei_number": [ "3008058231", "3033433849", "3030516433", "3026311463", "3008881803", "3006513362", "1317511", "3002572935", "1831750", "3004574120", "3011719874", "3030019986", "3008791302", "1318843", "3003600763", "3006802326", "3012398026", "3006891315", "3017181414", "3011659880", "1043568", "3003749961", "3006795806", "3015286905", "3005706637" ], "device_name": "Bed, Pediatric Open Hospital", "medical_specialty_description": "General Hospital", "regulation_number": "880.5140", "device_class": "2" } } ] }