{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "114411",
      "product_res_number": "Z-0467-2013",
      "event_date_initiated": "2012-10-26",
      "event_date_posted": "2012-12-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-09-26",
      "res_event_number": "63646",
      "product_code": "ISW",
      "product_description": "BiOM Rechargeable Li Ion 22.2 V Battery and BiOM Lithium Battery Charger sold as an accessory to the BiOM lower leg system:\r\nProduct Number: 2001249 BiOM Battery\r\nProduct Number: 2001240 BiOM Charger",
      "code_info": "Product Code: 2001249 (BiOM Battery) ,Lot number:48831 Product Code: 2001240 (Charger), Lot number: 2973",
      "firm_fei_number": "3008869754",
      "recalling_firm": "iwalk inc",
      "address_1": "4 Crosby Dr",
      "city": "Bedford",
      "state": "MA",
      "postal_code": "01730-1402",
      "additional_info_contact": "781-761-1560",
      "reason_for_recall": "Battery may over-heat during charging and smoke",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "iWalk notified customers directly by sales representatives by telephone on October 26, 2012, and instructedthem  to stop use of the battery and charger and return them to iWalk. Accounts provided with  Return Material Authorizations (RMA).\r\nFor questions regarding this recall call 781-761-1560.",
      "product_quantity": "21 Batteries; 9 Chargers",
      "distribution_pattern": "Nationwide Distribution including OH, NC, and NY.",
      "openfda": {
        "k_number": [
          "K991590"
        ],
        "registration_number": [
          "3010220187",
          "1721652",
          "3008584163",
          "3006943846",
          "3027645766",
          "3004737223",
          "3007123908",
          "3004134478",
          "3003855936",
          "3014827594"
        ],
        "fei_number": [
          "3010220187",
          "1721652",
          "3008584163",
          "3006943846",
          "3027645766",
          "3004737223",
          "3007123908",
          "3004134478",
          "3003855936",
          "3014827594"
        ],
        "device_name": "Assembly, Knee/Shank/Ankle/Foot, External",
        "medical_specialty_description": "Physical Medicine",
        "regulation_number": "890.3500",
        "device_class": "2"
      }
    }
  ]
}