{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Burnaby",
      "state": "N/A",
      "country": "Canada",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "77901",
      "recalling_firm": "NOVADAQ TECHNOLOGIES INC.",
      "address_1": "8329 Eastlake Dr Unit 101",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide Distribution. US (nationwide) to states of:  CA, CO, ID, IL, NY, OR, and VA; and countries of: Canada, Belgium, and Lithuania.",
      "recall_number": "Z-3235-2017",
      "product_description": "NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies Inc., Burnaby, BC, Canada, Assembled by Carestream  Health, Inc., Rochester, NY.    The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up of equipment after surgery or other medical procedures. The product is not intended to be used as patient drapes and they have no patient contact.",
      "product_quantity": "16/6-drape kits",
      "reason_for_recall": "The sterile drape material may contain a pinhole compromising its integrity resulting in a breach of the sterile barrier.",
      "recall_initiation_date": "20170627",
      "center_classification_date": "20170928",
      "termination_date": "20171211",
      "report_date": "20171004",
      "code_info": "PAQ lot #1704B containing drape lot #1703251; PAQ lot #1704F containing drape lot #1703291; and PAQ lot #17046 containing drape lot #1703251."
    }
  ]
}