{ "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": "123235", "product_res_number": "Z-0839-2014", "event_date_initiated": "2013-09-17", "event_date_posted": "2014-01-27", "recall_status": "Terminated", "event_date_terminated": "2017-06-05", "res_event_number": "66742", "product_code": "ILO", "product_description": "DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849.\r\n\r\nPhysical Therapy.", "code_info": "Lot Numbers: 32901129, 32980912, 33015541, 33024746, 33105239", "firm_fei_number": "3003040625", "recalling_firm": "DeRoyal Industries Inc", "address_1": "1595 Highway 33 S", "city": "New Tazewell", "state": "TN", "postal_code": "37825-7105", "additional_info_contact": "Tracy Edmundson\n865-362-2334", "reason_for_recall": "The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.", "root_cause_description": "Device Design", "action": "DeRoyal sent a \"URGENT VOLUNTARY RECALL DEROYAL HOT/COLD THERAPY UNIT\" letter dated September 17, 2013. The letter identified the product, problem, and actions to be taken by the customers.", "product_quantity": "25 units", "distribution_pattern": "Nationwide Distribution.", "openfda": { "k_number": [ "K925677", "K801301", "K884255", "K891091", "K900356", "K923643", "K964354", "K961855", "K760804", "K832820", "K891603", "K955326", "K955057", "K962537", "K963261", "K926151", "K945067", "K915196", "K944971", "K945853", "K904998", "K760910", "K930918", "K970533", "K940160", "K890852", "K940429", "K761254", "K832819", "K072152", "K902269", "K953532", "K760782", "K891152", "K893706", "K040317", "K921540", "K945399", "K830757", "K890853", "K902268", "K930634", "K931203", "K943497", "K891092", "K912722", "K964710", "K910061", "K940858", "K070402", "K852495", "K883681", "K961425", "K962983", "K964057", "K950711", "K760527", "K920581", "K970197", "K871962", "K945467", "K931843", "K871963", "K791162", "K954095", "K911943", "K083008", "K780452", "K073675", "K936143", "K833564", "K934262", "K950395", "K882310", "K955529", "K914434", "K913729", "K973023", "K913026", "K943844", "K961621", "K213097", "K942882", "K935841", "K900355", "K963596", "K843146", "K945468", "K944447", "K914182", "K891151", "K964006", "K964799" ], "registration_number": [ "3010675856", "", "1060680", "3018269548", "3013002868", "2030732", "1058584", "2029275", "3007309299", "1417592", "3007582661", "3042254805", "3033511104", "3011529836", "3027500264", "3021282523", "3003764610", "3003890514", "1531264", "3017264244", "3011491271", "3033845665", "3012157621", "3007543825", "3011853381", "3030478415", "3004116008", "3017965926", "3042284335", "3004713344", "3011539161", "1055823", "3007774549", "1835315", "3045077467", "3043140701", "3008523132", "3007109661", "3015501220", "9611559", "3009142693", "3014834638", "3010160370", "3030648824", "8043817", "1528161", "3017150671", "3043709874", "3025430561", "2028253", "3015004731", "1649518", "3033648890", "3012841710", "3014542717", "3018109879", "3006416350", "1000548922", "3025034781", "3015907115", "3009155756", "3023876581", "1834003", "3010694026", "3016969935", "1723702", "3026294985", "3017866840", "3021380980", "3015489752", "3015252349", "3007353136", "3011270181", "9680425", "3017555752", "3015960622", "3013180212", "3030151584", "3013069546", "3005730446", "9613793", "1648700", "3014386328", "3038295706", "1043214", "3008724689", "3030387297", "3009125070", "3032062344", "3010251529", "3016915446", "3035374295", "3010960892", "3016171827", "9616086", "3009437400", "3019849074", "3003855981", "1927395", "3007649424", "3015727296", "3014264913", "3004605321", "3016746289", "3037609256", "3015619973", "3016159364", "3008395114", "2424387", "3011689956", "3027643666", "3003619590", "3008570882", "3027328721", "3011684767", "3003542872", "9616309", "1516825", "3030446844", "1054241", "2320762", "2011068", "3031646688", "3011191255", "3017202421", "3011767724", "3008236846", "3042277508" ], "fei_number": [ "3010675856", "", "1000219637", "3018269548", "3013002868", "3007309299", "1000208624", "1417592", "3007582661", "3042254805", "3003040625", "3033511104", "3011529836", "3027500264", "3021282523", "3003764610", "3003890514", "3017264244", "3011491271", "1000139922", "3033845665", "2937446", "3003750857", "3012157621", "3007543825", "3011853381", "3030478415", "3004116008", "3017965926", "3042284335", "3004713344", "3011539161", "3007774549", "3007596547", "3001236277", "3045077467", "3043140701", "3008523132", "1000125378", "3007109661", "3015501220", "3009142693", "1000306431", "3014834638", "3010160370", "3000204953", "3030648824", "3017150671", "3043709874", "3025430561", "3033648890", "3015004731", "3012841710", "3014542717", "3006076154", "3018109879", "3003255513", "3006416350", "1000548922", "3025034781", "3015907115", "3009155756", "3002865632", "3000204260", "3023876581", "3010694026", "3016969935", "3026294985", "3017866840", "3021380980", "3015489752", "3015252349", "3007353136", "3011270181", "3017555752", "3015960622", "3013180212", "3030151584", "3013069546", "3005730446", "3014386328", "3038295706", "1043214", "3008724689", "3030387297", "3009125070", "3032062344", "3010251529", "1000111140", "3016915446", "3035374295", "3010960892", "3016171827", "3009437400", "3019849074", "3003855981", "1927395", "3007649424", "3015727296", "3014264913", "3004605321", "3016746289", "3037609256", "1000112877", "3015619973", "3016159364", "3008395114", "3000215572", "2424387", "3011689956", "3027643666", "3003094575", "3003619590", "3027328721", "3006469671", "3011684767", "3003542872", "1516825", "3030446844", "1000122747", "2011068", "3031646688", "3011191255", "3017202421", "3000210417", "3011767724", "3008236846", "3042277508" ], "device_name": "Pack, Hot Or Cold, Water Circulating", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.5720", "device_class": "2" } } ] }