{
  "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": "2026-10-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
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  },
  "results": [
    {
      "cfres_id": "222476",
      "product_res_number": "Z-0306-2027",
      "event_date_initiated": "2026-09-09",
      "event_date_posted": "2026-10-28",
      "recall_status": "Open, Classified",
      "res_event_number": "99782",
      "product_code": "ODG",
      "k_numbers": [
        "K200090"
      ],
      "product_description": "PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.",
      "code_info": "Model No. EG36-J10UR; UDI-DI: 04961333239573, 04961333239580, 04961333239597, 04961333239603, 04961333239627, 04961333248919, 04961333248926, 04961333248933, 04961333248957, 04961333252756; All Serial Numbers.",
      "firm_fei_number": "1000080301",
      "recalling_firm": "Pentax of America Inc",
      "address_1": "3 Paragon Dr",
      "city": "Montvale",
      "state": "NJ",
      "postal_code": "07645-1782",
      "additional_info_contact": "PENTAX Medical Customer Service\n800-431-5880",
      "reason_for_recall": "Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "An Urgent Field Safety Notice dated 09/02/2026 was mailed to consignees. The notice informs consignees of two updates to the IFU of PENTAX Medical products, specifically the ultrasound endoscope devices and water bottle assembly. Consignees are to inform their staff of this notice and include the warning and updates to their IFUs. Additionally, consignees are instructed to change water for each procedure and fill the bottle approximately 2/3 full, or to the 200 marking on the bottle scale, with sterile water. If the water/balloon feeding function does not work consignees are to fill the water bottle with deaerated sterile water. PENTAX Medical can be contacted by phone at 1-800-431-5880 Monday through Friday from 8:30 AM EST to 5:00 PM EST, or by email at customeradvisories@pentaxmedical.com.",
      "product_quantity": "84 units",
      "distribution_pattern": "Worldwide - US Nationwide and International distribution - Pending.",
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        "device_name": "Endoscopic Ultrasound System, Gastroenterology-Urology",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2"
      }
    }
  ]
}