{
  "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": [
    {
      "country": "United States",
      "city": "Portage",
      "address_1": "4100 E Milham Ave",
      "reason_for_recall": "Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.",
      "address_2": "",
      "product_quantity": "5988",
      "code_info": "1. Lot Numbers: 17283012, 17284012, 17286012; 2. Lot Numbers: 17278012, 17280012, 17282012, 17283012, 17285012, 17289012, 17292012; 3. Lot Number: 17279012; 4. Lot Number: 17284012      UDI: (01)4546540861641;   (01)4546540861764;  (01)4546540861818;  (01)4546540144300",
      "center_classification_date": "20180328",
      "distribution_pattern": "Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.",
      "state": "MI",
      "product_description": "1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300      for orthopedic use.",
      "report_date": "20180404",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Stryker Instruments Div. of Stryker Corporation",
      "recall_number": "Z-1246-2018",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "79418",
      "termination_date": "20190416",
      "more_code_info": "",
      "recall_initiation_date": "20171109",
      "postal_code": "49002-9704",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}