{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 4 } }, "results": [ { "cfres_id": "219284", "product_res_number": "Z-2134-2026", "event_date_initiated": "2026-03-19", "event_date_posted": "2026-05-08", "recall_status": "Open, Classified", "res_event_number": "98638", "product_code": "ILO", "product_description": "Brand Name: DONJOY\nProduct Name: ICEMAN CLASSIC CUBE\nModel/Catalog Number: 11-0494\nSoftware Version: no\nProduct Description: 11-0494 - ICEMAN CLASSIC CUBE\nThe IceMan CLASSIC3 cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology.\nComponent: no", "code_info": "Model/Catalog Number: 11-0494\nLot Code: Lots: 146894, 146895, 146856, 146857\nGTIN: 00888912003100", "firm_fei_number": "3017264244", "recalling_firm": "DJO, LLC", "address_1": "5919 Sea Otter Pl Ste 200 5919 Sea Otter Pl", "address_2": "Ste 200", "city": "Carlsbad", "state": "CA", "postal_code": "92010-6750", "additional_info_contact": "Kenneth Newman\n682-299-9133", "reason_for_recall": "Due to broken connector which may result in a temporary interruption of prescribed cold therapy.", "root_cause_description": "Process control", "action": "On 03/19/2026, the firm emailed an \"Urgent: Medical Device Recall\" Letter to customers to inform them that, twenty-nine complaints have been received reporting a consistent failure mode described as a broken connector. The connector is the component that attaches the end of the circulating hose from the cooler to the pad which is placed on/around the affected limb. Excess water leakage from this component is a key indicator of breakage.\n\nCustomers are instructed to:\nEnovis (DJO, LLC) requires customers to take the following actions by 03-31-2026:\nThis notice must be forwarded to all those within their organization or to any organization where the affected product has been transferred.\n1. Review stock of the affected products and lot numbers to be returned. Quantities or affected product previously shipped are listed in the table at the opening of this letter.\n2. Quarantine these devices from sale.\n3. Complete the attached acknowledgment and response form and return to (Customer.Care@enovis.com).\n4. To return affected product, please contact (Customer.Care@enovis.com) or call (800) 336-6569 option 4 and customers will be provided with a shipping label to return the affected product.\n5. Return all affected products using the shipping label provided.\n\nFor questions - contact Kenneth Newman at productsafety@enovis.com or call/text 682-299-9133.", "product_quantity": "596", "distribution_pattern": "Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.", "openfda": { "k_number": [ "K921540", "K961855", "K902269", "K931203", "K910061", "K915196", "K871962", "K970533", "K883681", "K945468", "K935841", "K891603", "K944447", "K843146", "K912722", "K893706", "K871963", "K891152", "K940858", "K973023", "K891092", "K920581", "K780452", "K964354", "K945067", "K942882", "K900355", "K791162", "K083008", "K945467", "K761254", "K073675", "K926151", "K213097", "K944971", "K913729", "K760804", "K945399", "K950711", "K945853", "K964057", "K961621", "K964710", "K940160", "K832820", "K963596", "K955529", "K760782", "K963261", "K904998", "K925677", "K934262", "K902268", "K911943", "K832819", "K890852", "K953532", "K930634", "K884255", "K950395", "K923643", "K882310", "K961425", "K964799", "K940429", "K943844", "K914434", "K900356", "K830757", "K964006", "K954095", "K760527", "K891151", "K930918", "K955326", "K913026", "K760910", "K852495", "K936143", "K891091", "K914182", "K070402", "K943497", "K955057", "K970197", "K962983", "K833564", "K801301", "K890853", "K962537", "K072152", "K040317", "K931843" ], "device_name": "Pack, Hot Or Cold, Water Circulating", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.5720", "device_class": "2", "registration_number": [ "3027500264", "3011853381", "3004713344", "1060680", "3011539161", "3015489752", "3017965926", "3030387297", "3030648824", "3025034781", "3047904066", "1648700", "3015004731", "3010694026", "9611559", "3042254805", "3021380980", "3014386328", "1058584", "3021282523", "3033845665", "3010675856", "3017866840", "3033648890", "3011684767", "1043214", "3007353136", "3012841710", "1000548922", "1835315", "3008395114", "3010960892", "3015960622", "3015619973", "3008724689", "3042277508", "3016171827", "3011529836", "3035374295", "3031646688", "3007309299", "3016915446", "3010160370", "3014834638", "3013069546", "9680425", "3015501220", "3017202421", "9616086", "3018269548", "3025430561", "3007649424", "3018109879", "3009155756", "3003542872", "3012157621", "3032062344", "3017264244", "3016746289", "1054241", "3045077467", "2028253", "3030151584", "3004605321", "1055823", "3015727296", "2011068", "3011491271", "3015907115", "3014542717", "3027328721", "3006416350", "3033511104", "9616309", "3005730446", "3009125070", "1927395", "3008523132", "3017150671", "3011689956", "3017936974", "3007774549", "2424387", "3008570882", "3009142693", "9613793", "3013180212", "8043817", "3011270181", "3017555752", "3026294985", "3038295706", "1531264", "3016159364", "3037609256", "3027643666", "1834003", "3007582661", "3030446844", "3015252349", "3019849074", "1417592", "3011191255", "3043140701", "3003855981", "3003890514", "3007109661", "3016969935", "3007543825", "2320762", "3009437400", "1649518", "2029275", "3042284335", "3010251529", "2030732", "3008236846", "3003619590", "1516825", "1528161", "3004116008", "3023876581", "3011767724", "3043709874", "3013002868", "3014264913", "3003764610", "3030478415" ], "fei_number": [ "3027500264", "1000122747", "3011853381", "3004713344", "1000208624", "3011539161", "1000112877", "3015489752", "3017965926", "3030387297", "3030648824", "3002865632", "3025034781", "3047904066", "3015004731", "3010694026", "3003094575", "3042254805", "1000125378", "3021380980", "3014386328", "3021282523", "3033845665", "3010675856", "3017866840", "1000306431", "3033648890", "3003040625", "3011684767", "3003255513", "1043214", "3007353136", "3012841710", "1000548922", "3008395114", "3010960892", "3015960622", "3015619973", "3000210417", "3008724689", "3042277508", "3016171827", "3011529836", "3035374295", "3031646688", "3007309299", "1000139922", "3016915446", "3010160370", "1000111140", "3014834638", "3013069546", "3015501220", "3017202421", "3018269548", "3025430561", "3007649424", "3018109879", "3009155756", "3003542872", "3012157621", "3032062344", "3017264244", "3016746289", "3045077467", "3030151584", "3006076154", "3004605321", "3015727296", "2011068", "1000219637", "3011491271", "3015907115", "3014542717", "3027328721", "3006416350", "3033511104", "3005730446", "3009125070", "3006469671", "1927395", "3008523132", "3017150671", "3001236277", "3011689956", "3017936974", "3007774549", "2424387", "3009142693", "3013180212", "3011270181", "3017555752", "3026294985", "3038295706", "3016159364", "3037609256", "3027643666", "3000204260", "3007582661", "3030446844", "3015252349", "3019849074", "1417592", "3011191255", "3043140701", "3003855981", "3003890514", "3007109661", "3016969935", "3007543825", "3009437400", "3003750857", "3042284335", "3000204953", "3010251529", "3008236846", "3003619590", "3007596547", "1516825", "3004116008", "3023876581", "2937446", "3011767724", "3043709874", "3013002868", "3014264913", "3003764610", "3030478415" ] } } ] }