{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "90986",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "100 Boston Scientific Way",
      "address_2": "N/A",
      "postal_code": "01752-1234",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and (Foreign) countries of: Algeria Argentina Argentina Australia Austria Bahrain Belgium Brazil Canada Chile Colombia Costa Rica Cyprus Czech Republic Denmark Ecuador Egypt Finland France Germany Great Britain Greece Hong Kong Hungary Iceland Iraq Ireland Israel Italy Jordan Kuwait Latvia Lebanon Lithuania Luxembourg Mexico Netherlands New Zealand Norway Oman Palestine Panama Per¿ Poland Portugal Romania Russian Fed. Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Unit.Arab Emir. Zimbabwe",
      "recall_number": "Z-0226-2023",
      "product_description": "ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps,  adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.\t\t\t\t                                                                                      UPN\t\t\t\t\t\t\t\t\t\t\t  (1)ORISE ProKnife 1.5 mm Electrode - Kit\t     M00519380;\t\t\t\t\t\t\t  (2) ORISE ProKnife 2.0 mm Electrode - Kit     M00519390;\t\t\t\t\t\t\t\t  (3) ORISE ProKnife 3.0 mm Electrode - Kit     M00519400",
      "product_quantity": "402,968 Total",
      "reason_for_recall": "***Update12/13/22***:Product removal due to higher incidence of adverse events of foreign body reactions***  Potential outcomes associated with foreign body reaction to remnant ORlSE Gel post procedure. Foreign body reaction which presented as mass formations from remnant ORlSE Gel post-procedure, prompting  surgical intervention",
      "recall_initiation_date": "20221010",
      "center_classification_date": "20221110",
      "report_date": "20221116",
      "code_info": "GTIN Number :         (1)08714729995586          (2)08714729995593          (3)08714729995609                   All batches"
    }
  ]
}