{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Plymouth",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "73948",
      "recalling_firm": "Greatbatch Medical",
      "address_1": "2300 Berkshire Ln N",
      "address_2": "N/A",
      "postal_code": "55441-4575",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: IN, MI, TX.  OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.",
      "recall_number": "Z-1882-2016",
      "product_description": "Torque Limiting Handle:  PRECIMED, T-Handle Torque, Non Sterile.    Handle:  Customer Number/Model:  MCL120014   T14000,  TLT911-50-S20   TLT911-50-S20,   TLT911-15-S01   TLT911-15-S01,  TLTS0007-20-S19   TLTS0007-20-S19,   TLT911-35-S01   TLT911-35-S01.",
      "product_quantity": "2",
      "reason_for_recall": "Greatbatch Medical has initiated a global Field Recall  for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not  achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction  For Use (IFU) provided with the device.",
      "recall_initiation_date": "20160426",
      "center_classification_date": "20160601",
      "termination_date": "20180607",
      "report_date": "20160608",
      "code_info": "6307760001"
    }
  ]
}