{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "187262", "product_res_number": "Z-1950-2021", "event_date_initiated": "2021-04-19", "event_date_created": "2021-06-24", "recall_status": "Open, Classified", "res_event_number": "87864", "product_code": "IKY", "product_description": "Econocare Plus Waffle Overlay- Intended for use as a medical device to aid in the prevention and treatment of pressure injuries or bed sores and general comfort.\nProduct Code: 1025ECP", "code_info": "Lot Number: 105013A", "firm_fei_number": "1832066", "recalling_firm": "EHOB, Inc.", "address_1": "250 N Belmont Ave", "city": "Indianapolis", "state": "IN", "postal_code": "46222-4265", "additional_info_contact": "SAME\n317-972-4600", "reason_for_recall": "Product contamination-a trace amount of dried bodily fluids may expose patients, health care providers to contaminates", "root_cause_description": "Process control", "action": "EHOB issued recall notification Urgent Medical Device Recall letter 0n 4/19/21 via electronically tracked signature documents. The letter states reason for recall, health risk and action to take:\nProducts should not be removed from their box as they are packaged in an arrangement to eliminate exposure via individually sealed plastic bag\ncontainers inside the corrugate box. Do not open the sealed plastic bags that the products are contained in. This recall notice is temporary, is limited to the identified lot of this product, and does not cause a shortage of availability. Additionally, all other lot numbers of this product are safe for use and available\nfor distribution.\nThis product is to be returned to the EHOB Indianapolis Distribution Center at the address listed below.\nPlease contact our Customer Service department at customerservice@ehob.com or (317) 972-4600 to arrange free return shipment.\nFor additional information regarding this notice, you may contact Aaron Kadel, Vice President Engineering and Quality at (800) 899-5553; Monday Friday 9 AM 4 PM .", "product_quantity": "70 units", "distribution_pattern": "US Nationwide distribution in the states of AZ, IN, ME, NE, OH, SD.", "openfda": { "k_number": [ "K802833", "K802781", "K772062", "K780779", "K813226", "K914921", "K760963", "K771824" ], "registration_number": [ "3014256531", "3015772781", "3013564718", "3015423385", "3015286905", "3017642731", "3012392312", "2435947", "3004116007", "2032121", "3039346864", "3007798904", "1836047", "3010865451", "3032252823", "3010515377", "1043615", 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"3003542872", "3018115503", "3007309299", "3035380696" ], "device_name": "Mattress, Flotation Therapy, Non-Powered", "medical_specialty_description": "General Hospital", "regulation_number": "880.5150", "device_class": "1" } } ] }