{ "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": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "New Windsor", "state": "NY", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "79858", "recalling_firm": "Ondamed Inc", "address_1": "80 Waterview Ter", "address_2": "N/A", "postal_code": "12553-5904", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution - USA (nationwide) and to the counties of : Canada and Taiwan.", "recall_number": "Z-1782-2018", "product_description": "Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training and muscle re-education and prescription use.", "product_quantity": "585", "reason_for_recall": "The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has notified customers that an upgrade for the device is now available, which includes the addition of direct readout and audio signals for heart rate, and visual patient readout of blood oxygen content SpO2.", "recall_initiation_date": "20170707", "center_classification_date": "20180510", "termination_date": "20200424", "report_date": "20180516", "code_info": "M011007 M011012 M011013 M011021 M011022 M011026 M011027 M011028 M030202 M030204 M030205 M030211 M030211b (Dup) M030212 M030213 M030217 M030218 M030219 M030222 M030225 M030226 M030227 M030228 M030229 M030230 M030231 M030232 M030238 M030242 M030244 M030246 M030247 M030248 M030249 M040201 M040202 M040203 M040204 M040207 M040208 M040209 M040210 M040218a M040218b M040218c M040219 M040220 M040221 M040221a M040222 M040223 M040224 M040225 M040226 M040237 M040238 M040242 M040243 M040245 M040246 M040248 M040248a M040253 M040254 M040255 M040260 M050400 M050413 M050414 M050415 M050416 M050419 M050419a M050420 M050421 M050423 M050425 M050426 M050428 M050430 M050431 M050431 M050432a M050436 M050438 M050439 M050440 M050447 M050447a M050453 M050456 M050457 M050458 M051101 M051102 M051103 M051105 M051110 M051111 M051112 M051113 M051114 M051115 M051116a M051120 M051121 M051124 M051125 M051133 M051134 M051135 M051136 M051138 M051142 M051143 M051146 M051147 M051154 M051155 M060701 M060702 M060703 M060704 M060706 M060707 M060713 M060714 M060715 M060716 M060717 M060718 M060719 M060720 M060727 M060728 M060729 M060730 M060731 M060732 M060733 M060734 M060739 M060740 M060741 M060742 M060744 M060747 M060748 M060748a M060749 M060750 M060751 M060752 M060753 M07003 M07004 M07005 M07006 M07008 M07009 M07011 M07012 M07013 M07014 M07015 M07016 M07017 M07018 M07021 M07026 M07027 M07028 M07029 M07030 M07031 M07032 M07033 M07040 M07040a M07041 M07041 M07042 M07043 M07046 M07047 M07048 M07049 M07051 M07053 M07059a M07060 M07062 M07065 M07066 M07067 M07068 M07069 M07070 M07071 M07072 M07075 M07076 M07078 M07079 M07080 M07082 M07083 M07084 M07085 M07086 M07088 M07090 M07091 M07092 M07093 M07094 M07095 M07096 M07097 M07123 M07128 M07132 M08002 M08003 M08003a M08004 M08007 M08008 M08010 M08011 M08012 M08013 M08014 M08015 M08018 M08019 M08020 M08022 M08023 M08024 M08026 M08027 M08029 M08030 M08037 M08038 M08039 M08040 M08041 M08042 M08043 M08044 M08048 M08049 M08050 M08051 M08051a M08052 M08053 M08054 M08055 M08062 M08063 M08067 M08068b M08071 M08072 M08074 M08075 M08076 M08077 M08079 M08080 M08081 M08082 M08083 M08085 M08086 M08087 M08090 M08093 M08094 M09000 M09002 M09003 M09005 M09006 M09008 M09012 M09013 M09017 M09018 M09032 M09034 M09036 M09039 M09040 M09041 M09042 M09043 M09044 M09045 M09046 M09050 M09051 M09054 M09057 M09057a M09064 M09067 M09074 M09075 M09086 M09087 M09088 M09089 M09090 M09091 M09091a M09092 M09095 M10003 M10004 M10011 M10012 M10016 M10017 M10024 M10028 M10029 M10030 M10031 M10032 M10034 M10035 M10036 M10042 M10043 m10043a M10044 M10045 M10046 M10047 M10056 M10057 M10058 M10060 M10061 M10062 M10063PT M10064 M10065 M10078 M10102 M10103 M10105 M10109 M10112 M10113 M10114 M10114a M10115 M11002 M11003 M11007 M11009 M11010 M11011 M11012 M11015 M11016 M11021 M11022 M11023 M11024 M11027 M11028 M11029 M11030 M11033 M11034 M11035 M11036 M11038 M11041 M11043 M11044 M11044a M11045 M11045a M11046 M11047 M11048 M11049 M11050 M11050 M11059 m11060 M11061 M11063 M11064 M11071 M11072 M11073 M11074 M11076 M11080 M11081 M11082 M11083 M11084 M11085 M12001 M12002 M12003 M12007 M12008 M12009 M12010 M12011 M12021 M12022 M12024 M12025 M12027 M12028 M12031 M12033 M12034 M12035 M12036 M12037 M12039 M12042 M12043 M12043 M12044 M12045 M12052 M12054 M12055 M12059 M12067 M13001 M13002 M13003 M13004 M13012 M13013 M13015 M13016 M13017 M13018 M13019 M13020 M13021 M13022 M13023 M13031 M13036 M13037 M13041 M13043 M13044 M13046 M13048 M13049 M13050 M13051 M13053 M13054 M13057 M13058 M13061 M13062 M13063 M13064 M13065 M13066 M13067 M13073 M13074 M14002 M14008 M14015 M14015a M14017 M14017a M14018 M14019 M14020 M14026 M14027 M14032 M14035 M14036 M14037 M14038 M14039 M14041 M14046 M14050 M14051 M14052 M14053 M14054 M14055 M14056 M14057 M15001a M15002 M15003 M15004 M15006 M15008 M15012 M15014a M15017 M15028 M15030 M15031 M15031a" } ] }