{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "167425", "product_res_number": "Z-0094-2019", "event_date_initiated": "2018-08-31", "event_date_created": "2018-10-10", "recall_status": "Terminated", "event_date_terminated": "2018-12-21", "res_event_number": "81085", "product_code": "ESD", "product_description": "Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10\n\nIntended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.", "code_info": "Serial numbers 024569 and 024550", "firm_fei_number": "3003557127", "recalling_firm": "Widex A/S", "address_1": "Nymollevej 6 6 nymollevej", "city": "Lynge", "country": "Denmark", "reason_for_recall": "The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.", "root_cause_description": "Employee error", "action": "The firm, Widex, sent an \"Urgent Medical Device Correction Letter\" dated 8/28/18 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:\na) Investigate, whether your childs BABY440 hearing aid is mounted with the correct battery drawer. Please refer to the attachment How to determine if correct battery drawer is mounted.\nb) If affirmative, return the product to the hearing care professional, where you bought the hearing aid, to have the tamper-resistant battery drawer mounted.\n\nIf you have any questions, contact Director, Global Regulatory Affairs at 0045 44 35 57 71 or email to: krpe@widex.com.", "product_quantity": "2", "distribution_pattern": "US Distribution to states of: GA and NY.", "openfda": { "k_number": [ "K854637", "K802382", "K923918", "K874831", "K965218", "K940177", "K950692", "K971804", "K952450", "K830790", "K901316", "K944039", "K901642", "K781513", "K874218", "K800113", "K911063", "K862103", "K931134", "K892338", "K941508", "K935335", "K941734", "K790697", "K943960", "K864028", "K911708", "K874651", "K922422", "K843921", "K944984", "K946045", "K971699", "K873560", "K942831", "K912570", "K971158", "K935266", "K963873", "K801003", "K931000", "K944986", "K926476", "K900830", "K892803", "K935327", 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