{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Vista",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "85445",
      "recalling_firm": "DJO, LLC",
      "address_1": "3151 Scott St",
      "address_2": "N/A",
      "postal_code": "92081-8365",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and WV    The countries of Algeria, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Congo, Congo, The Democratic Republic of the, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, England, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Republic of, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, United Republic of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Viet Nam.",
      "recall_number": "Z-2590-2020",
      "product_description": "This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a patient.",
      "product_quantity": "41,801 units",
      "reason_for_recall": "The device accessories were not labeled with appropriate latex warning.",
      "recall_initiation_date": "20180625",
      "center_classification_date": "20200713",
      "termination_date": "20221115",
      "report_date": "20200722",
      "code_info": "Part Number/ Description:  10679/ NYLATEX 4X36 PKG SING FOR UNIT  10827/ NYLATEX 2-1/2 X 18 CUT  10828/ NYLATEX 2-1/2X18 SEWN  10829/ NYLATEX 2-1/2X36 CUT  10830/ NYLATEX 2-1/2X36 SEWN  10831/ NYLATEX 2-1/2X48 CUT  10832/ NYLATEX 2-1/2X48 SEWN  10833/ NYLATEX 4X18 CUT  10834/ NYLATEX 4X18 SEWN  10835/ NYLATEX 4X36 CUT  10836/ NYLATEX 4X36 SEWN  10837/ NYLATEX 4X48 CUT  10838/ NYLATEX 4X48 SEWN  10839/ NYLATEX 6X18 CUT  10840/ NYLATEX 6X18 SEWN  10841/ NYLATEX 6X36 CUT  10842/ NYLATEX 6X36 SEWN  10843/ NYLATEX 6X48 CUT  10844/ NYLATEX 6X48 SEWN  12-0248-8/ NYLATEX 2-1/2X24 CUT  1210CHT/ NYLATEX 4X36 BAG OF 3  1214CHT/ NYLATEX 6X18 BAG OF 3  1213CHT/ NYLATEX 4X60 BAG OF 3  19991/ NYLATEX 6X60 CUT  19992 /NYLATEX 6X60 SEWN  19993/ NYLATEX 4X60 CUT  19994/ NYLATEX 4X60 SEWN  25-10648/ NYLATEX 2-1/2X24  25-10679/ NYLATEX 4X36  12-10648/ NYLATEX 2-1/2 X 24 SEWN  12-8655/ ASSY,STIM MODULE CH 3/4 INT'L PKG  3448274/ C-5 220-240V OEM ENRAF W/PKS  2778-10/ INTELECT MOBILE COMBO, INT'L STD, 10CM APPL  2777/ INTELECT MOBILE 2CH STIMINT'L STD  2778/ INTELECT MOBILE COMBO, INT'L STD, 5CM APPL  2778-2/ INTELECT MOBILE COMBO, INT'L STD, 2CM APPL  5951/ INTELECT VITALSTIM 2 CHANNEL THERAPY SYSTEM, INT'L STD  2752CC/ INT ADV 2CH COLOR COMBO INT'L STD  2762CC/ INT ADV 2CH COLOR COMBO, INT'L 5CM APPL  2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD  2755CS/ INT ADV 2CH COLOR STIM INT'L STD  2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD, 2CM APPL  2765CS/ INT ADV 2CH COLOR STIM W/EMG INTL STD  2773MS/ INT ADVANCED STIM MONOCHROME INT'L STD  2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD, 10CM APPL  2770/ STIM MODULE CH 3/4 INT'L PKG  3102/ C-5 120V PKG A  3114/ C-5 220V PKG A INT'L STD  1200/ NYLATEX INTRO PACK  1202/ NYLATEX 2-1/2X18 BAG OF 3*  1204/ NYLATEX 2-1/2X36 BAG OF 3*  1206/ NYLATEX 2-1/2X48 BAG OF 3*  1208/ NYLATEX 4X18 BAG OF 3*  1210/ NYLATEX 4X36 BAG OF 3*  1212/ NYLATEX 4X48 BAG OF 3*  1213/ NYLATEX 4X60 BAG OF 3*  1214/ NYLATEX 6X18 BAG OF 3*  1216/ NYLATEX 6X36 BAG OF 3*  1218/ NYLATEX 6X48 BAG OF 3*  1219/ NYLATEX 6X60 BAG OF 3  1264/ NYLATEX 2-1/2X24 BAG OF 3*  10648/ NYLATEX 2-1/2X24 SEWN  28099/ KIT, LEAD IN MOBILE STIM INTL  59048/ KIT LEAD STIM INT CLINIC VITLS (CH 1/2)  27378/ KIT LEAD INT ADVANCED 2CH  27509/ KIT LED 4CH EPR INT L"
    }
  ]
}