{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Montvale",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88440",
      "recalling_firm": "Pentax of America Inc",
      "address_1": "3 Paragon Dr",
      "address_2": "N/A",
      "postal_code": "07645-1782",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "Z-2448-2021",
      "product_description": "Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel  Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L;  Colonoscope Family # 2-Pentax  Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK",
      "product_quantity": "28849 units Total",
      "reason_for_recall": "Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families",
      "recall_initiation_date": "20210714",
      "center_classification_date": "20210910",
      "report_date": "20210922",
      "code_info": "All devices distributed by Pentax in the US between April 2014 and May 2021",
      "more_code_info": ""
    }
  ]
}