{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "34793", "product_res_number": "Z-0004-05", "event_date_initiated": "2004-09-03", "event_date_posted": "2004-10-05", "recall_status": "Terminated", "event_date_terminated": "2007-01-26", "res_event_number": "29925", "product_code": "FIP", "k_numbers": [ "K922695" ], "product_description": "AmeriWater Portable RO+, model numbers MR01 and MR02. The device is a reverse osmosis system for dialysis.", "code_info": "Serial Numbers effected: 21013, 21014, 21026, 21031, 21042, 21052, 21053, 21071, 21072, 21073, 21079, 21080, 21090, 21091, 21092, 21100, 21101, 21110, 21111, 21121, 21122, 21125, 21127, 21193, 21194, 21200, 21201, 21203, 21204, 21205, 21208, 21210, 21215, 21222, 21223, 21236, 21237, 21240, 21258, 21259, 21263, 21270, 21328, 21333, 21336, 21338, 21352, 21371, 21379, 21384, 21387, 21388, 21015, 21016, 21017, 21021, 21023, 21024, 21032, 21033, 21034, 21035, 21036, 21043, 21049, 21050, 21051, 21054, 21066, 21089, 21093, 21094, 21095, 21097, 21098, 21108, 21109, 21123, 21126, 21128, 21142, 21143, 21156, 21157, 21160, 21162, 21163, 21164, 21165, 21166, 21167, 21168, 21169, 21176, 21178, 21179, 21180, 21183, 21185, 21186, 21191, 21192, 21212, 21216, 21217, 21224, 21225, 21228, 21229, 21244, 21249, 21260, 21268, 21269, 21271, 21272, 21274, 21275, 21276, 21282, 21283, 21298, 21299, 21300, 21302, 21307, 21311, 21316, 21329, 21332, 21339, 21342, 21343, and 21346.", "firm_fei_number": "1000515504", "recalling_firm": "Ameriwater Inc", "address_1": "1257 Stanley Ave", "city": "Dayton", "state": "OH", "postal_code": "45404-1013", "additional_info_contact": "Brian R. Bowman\n937-461-8833", "reason_for_recall": "The device has a potential risk of failure caused by faulty wiring within the electrical component. The wires can overheat and eventually break in two.", "root_cause_description": "Other", "action": "The firm notified consignee''s via letter sent on September 3, 2004. Consignees were provided in the letter with written instructions to correct the problem and were instructed to fax a return response form identifying that the corrections had been completed.", "product_quantity": "148 units.", "distribution_pattern": "Product was distributed in the following states: MI, HI, PA, IL, CA, CO, OH, TX, NY, SD, ON, IN, NC, MN, KY, SC, TN, FL, NJ, GA, MD, DE, AR, and MA.", "openfda": { "k_number": [ "K920186", "K090885", "K213507", "K112331", "K983512", "K030059", "K051620", "K072158", "K124059", "K974127", "K974899", "K945066", "K133829", "K894300", "K981680", "K133783", "K841403", "K083712", "K092481", "K003957", "K934848", "K002045", "K232953", "K931595", "K993200", "K102892", "K802474", "K991519", "K171099", "K250514", "K080703", "K030652", "K894106", "K223479", "K192398", "K251851", "K944385", "K011005", "K153329", "K915258", "K082400", "K021352", "K151637", "K994292", "K811678", "K010592", "K981085", "K863720", "K042089", "K991495", "K993806", "K131622", "K924695", "K041163", "K142285", "K945559", "K041884", "K800305", "K822385", "K123282", "K121022", "K873487", "K952215", "K211035", "K994279", "K022448", "K983126", "K131904", "K223656", "K061782", "K842215", "K771763", "K042797", "K250471", "K001755", "K001811", "K954928", "K143617", "K003877", "K182367", "K944767", "K013677", "K110285", "K944493", "K791086", "K945136", "K983239", "K991916", "K993520", "K992786", "K954349", "K060942", "K031832", "K030348", "K042018", "K071104", "K093608", "K001282", "K231410", "K000249", "K993877", "K111740", "K110578", "K133149", "K014169", "K022747", "K964539", "K980182", "K032004", "K871242", "K200670", "K043344", "K161304", "K021560", "K033648", "K252181", "K161844" ], "registration_number": [ "3010866895", "3005578748", "3017974963", "1530185", "9611824", "3007007791", "3010120135", "3002879653", "3006755813", "3006426779", "3019131", "3006029151", "3017552925", "1651723", "3004188066", "3014144799", "3010850471", "3010355846", "1225714", "3010041430", "3010120148", "3004111573", "3035708507", "3013507157", "9611823", "8010182", "3014279513", "3013764800", "3032828299", "3005695808", "1720309", "3015335038", "3038138522", "3038195011", "9610270", "3003768032", "1833920", "3009959868", "3010178296", "3003550196", "9615942", "9611369", "3004057358", "3010120326", "1833407", "1055109", "3012119281", "1651434", "3043543260", "3010863450", "3010867648", "8030665", "3043014136", "3002807295", "3003337893", "3010032903", "1833387", "3015349756", "3005162618", "3016096143" ], "fei_number": [ "3002807005", "3010866895", "3005578748", "3017974963", "1000518597", "3007007791", "3010120135", "3002879653", "3006755813", "3006426779", "1000191953", "3006029151", "3017552925", "3003043063", "3003110073", "3004188066", "3014144799", "3010850471", "3010355846", "3002807744", "3002807035", "3010041430", "3010120148", "3004111573", "3035708507", "1000515504", "1000112932", "3013507157", "3002807204", "1000115656", "3013764800", "3032828299", "3005695808", "1720309", "3015335038", "3038138522", "3038195011", "3003200197", "3009959868", "3003550196", "3004057358", "3012394756", "3006475063", "3010120326", "1527681", "3012119281", "3043543260", "3010863450", "3010867648", "3043014136", "3002807295", "3003337893", "3010032903", "3013942511", "1833387", "3002806960", "3015349756", "3014279513", "3016096143", "3001451489" ], "device_name": "Subsystem, Water Purification", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5665", "device_class": "2" } } ] }