{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "122354", "product_res_number": "Z-0115-2014", "event_date_initiated": "2013-09-27", "event_date_posted": "2013-10-30", "recall_status": "Terminated", "event_date_terminated": "2014-07-23", "res_event_number": "66410", "product_code": "INI", "k_numbers": [ "K102304" ], "product_description": "Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living.\n\nProducts can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.", "code_info": "Serial Numbers:  10390024, 10390025, 10390029, 10390030, 10390034, 10390037, 10490100, 10490108, 10490111, 10490113, 10490119, 10490121, 10490124, 11390058, 11390060, 11390061, 11390069, 11390074, 11390095, 11390101, 11490111, 11490147, 11490176, 11490189, 11490277, 11490304, 11490305, 11490425, 11490426, 11490433, 11490435, 11490445, 12390096, 12390097, 12390098, 12390099, 12390101, 12390102, 12390103, 12390104, 12390105, 12390106, 12390107, 12390117, 12390120, 12490169, 12490170, 12490172, 12490173, 12490174, 12490175, 12490176, 12490177, 12490178, 12490179, 12490180, 12490181, 12490182, 12490183, 12490184, 12490185, 12490186, 12490187, 12490188, 12490189, 12490190, 12490191, 12490192, and 12490193.", "firm_fei_number": "1000646143", "recalling_firm": "S.A.E. AFIKIM", "address_1": "Kibbutz Afikem Kibbutz", "city": "Afikim", "country": "Israel", "additional_info_contact": "Ofer Amitay\n800-809-3010", "reason_for_recall": "Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key.", "root_cause_description": "Process control", "action": "Afikim Electric Vehicles sent an URGENT: MEDICAL DEVICE RECALL letter, dated September 27, 2013, to all affected customers and distributors. .\n\nCustomers are advised to remove the ignition key and contact Afikim Electric Vehicles via telephone Monday through Friday at 1-800-809-3010 between the hours of 9AM and 5PM (EST). Consumers may also contact the company via e-mail at dov@afiscooters.com.\n\nCustomers are instructed to return the Recall Response Form by fax it to 800-466-1171 or email to ofer@afiscooters.com.\n\nConsumers should report any adverse event or quality problems to FDA's MedWatch Adverse Event Reporting program either by online, fax, or regular mail.", "product_quantity": "69 units", "distribution_pattern": "Nationwide Distribution: US including the states of California, Florida, Georgia, Illinois, Maine, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia, and Wisconsin.", "openfda": { "k_number": [ "K922966", "K172440", "K253631", "K840196", "K042763", "K220227", "K031315", "K030756", "K880425", "K000356", "K011473", "K002616", "K142912", "K971050", "K240272", "K983662", "K841919", "K023166", "K031897", "K063162", "K063196", "K031309", "K926296", "K083303", "K181344", "K895694", "K253936", "K063032", "K981121", "K253075", 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"K071007", "K242760", "K050042", "K033219", "K941966", "K926499", "K234098", "K032488", "K212090", "K222711", "K032277", "K023040", "K013927", "K033239", "K222729", "K170634", "K042012", "K031272", "K051130", "K080288", "K182471", "K040097", "K954974", "K905271", "K050792", "K172409", "K122749", "K983405", "K922305", "K012258", "K070602", "K242139", "K101507", "K955276", "K982144", "K926295", "K000354", "K024329", "K032879", "K900600", "K962583", "K991281", "K042011", "K250027", "K910751", "K191356", "K171256", "K101143", "K921647", "K852380", "K972037", "K940334", "K971388", "K944939", "K830345", "K895693", "K921467", "K013788", "K222507", "K072104", "K852557", "K041025", "K033116", "K260717", "K102361", "K051131", "K021910", "K252590", "K240012", "K030759", "K062676", "K252588", "K922338", "K041677", "K915416", "K952042", "K030758", "K092155", "K944940", "K143557", "K981885", "K050793", "K061912", "K072337", "K070802", "K220207", "K042104", "K003058", "K873500", "K081980", "K231428", 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"1000221992", "3033860076", "3014983822", "3017816603", "3043153502", "3003636180", "3003882673", "3042262539", "3008812160", "3003820676", "3016195086", "3019984611", "3002847480", "3016068274", "3006247243", "3022982004", "1000122747", "3012604975", "3020640553", "3029926469", "3019842343", "1000334118", "3012781455", "3011191255", "3008717361", "3004024088", "3014489639", "1000646143", "3030226288", "3026585646", "3044425292", "3039857114", "3012521614", "3012538618", "3033905189", "3030671633", "3004594214", "3032013112", "3004142507", "3003792251", "3013934051" ], "device_name": "Vehicle, Motorized 3-Wheeled", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3800", "device_class": "2" } } ] }