{
  "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": "203679",
      "product_res_number": "Z-0159-2024",
      "event_date_initiated": "2023-07-13",
      "event_date_posted": "2023-10-24",
      "recall_status": "Open, Classified",
      "res_event_number": "93215",
      "product_code": "POS",
      "k_numbers": [
        "K181861"
      ],
      "product_description": "Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest.\n\nModels:\n(1) Flamingo Pink   EM2-FP-S;\n(2) Sky Blue   EM2-SB-2; \n(3) Seoul Grey   EM2-SG-S; \n(4) Boston Blue   EM2-BB-S;\n(5) Milan Black   EM2-MB-S",
      "code_info": "UDI-DI:\n(1) Flamingo Pink  EM2-FP-S - 00853858006133;\n(2) Sky Blue  EM2-SB-2 - 00853858006140;\n(3) Seoul Grey  EM2-SG-S - 00853858006126;\n(4) Boston Blue   EM2-BB-S - 00853858006119;\n(5) Milan Black   EM2-MB-S - 00853858006102\n\nLot Numbers: G11/H11",
      "firm_fei_number": "3012933969",
      "recalling_firm": "EMPATICA SRL",
      "address_1": "Via Enrico Stendhal 36 36 via enrico stendhal",
      "city": "Milan",
      "country": "Italy",
      "reason_for_recall": "May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.",
      "root_cause_description": "Device Design",
      "action": "Empatica S.r.l issued Field Safety Notice via email on 7/14/23. Letter states reason for recall, health risk and action to take:\nYou can check your device lot number by:\n\" From the Alert App\nOn the home page of your MyEmbrace account on the right hand side of the screen you will see your Embrace Serial Number. The lot number is represented by the 5th, 6th and 7th digit of the serial number.\n\" On the packaging of your device\nOn the box that contained your Embrace2 there is an identification label (See picture below). The device Lot number is identified with the LOT symbol. In the picture below the device Lot number is F11.\nEmpatica recommends that you pay increased attention to the product battery level notifications intended to inform you about the remaining battery charge. As noted in the user manual, the Embrace device is not intended to be used as a stand-alone monitoring device. As the system is not meant to substitute for ongoing seizure monitoring practices, patients are strongly advised to ensure that alternative methods of obtaining medical assistance are available at all times, including during device charging sessions\nPatients are also encouraged to contact Empatica customer support for any concern related to battery life impacting usability of the Embrace device.\n\nCustomers contacted by the Empatica customer support team regarding battery duration are offered a free-of-charge replacement device.",
      "product_quantity": "1360 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.",
      "openfda": {
        "k_number": [
          "K172935",
          "K251506",
          "K200276",
          "K182180",
          "K250515",
          "K232915",
          "K181861",
          "DEN140033",
          "K243515",
          "K243199"
        ],
        "device_name": "Physiological Signal Based Seizure Monitoring System",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1580",
        "device_class": "2",
        "registration_number": [
          "3022175264",
          "3043349255",
          "3014886121",
          "3012933969",
          "3017084392",
          "3042639792"
        ],
        "fei_number": [
          "3022175264",
          "3043349255",
          "3014886121",
          "3012933969",
          "3017084392",
          "3042639792"
        ]
      }
    }
  ]
}