{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 4
    }
  },
  "results": [
    {
      "cfres_id": "222418",
      "product_res_number": "Z-3151-2026",
      "event_date_initiated": "2026-08-10",
      "event_date_posted": "2026-09-16",
      "recall_status": "Open, Classified",
      "res_event_number": "99758",
      "product_code": "OGD",
      "product_description": "Haylard 18G SINGLE SHOT EPI TRAY; \r\nModel/Item Number (Kit): DPGE002-02;",
      "code_info": "Model/Item Number (Kit): DPGE002-02;\nUDI-DI: 10809160410325;\nKit Lots: 1641713, 1641714, 1659697, 1668209;\nRecalled Sodium Chloride Ampule Lot: AB4003;",
      "firm_fei_number": "1047429",
      "recalling_firm": "AVID Medical, Inc.",
      "address_1": "9000 Westmont Dr",
      "city": "Toano",
      "state": "VA",
      "postal_code": "23168-9351",
      "additional_info_contact": "Marlene Jones\n470-280-4277",
      "reason_for_recall": "Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On August 10, 2026 URGENT: MEDICAL DEVICE RECALL letters were sent to customers.\nActions to be taken:\n1. Identify, Segregate, and Quarantine all impacted kits listed.\n2. Add warning labels to affected kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If pre-printed labels are needed, please contact your sales representative.\n3. REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use.\n4. Customers (end-users): If you have received product from a distributor, please contact the distributor or your sales representative with any questions you may have.\n5. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness.\n6. Complete the attached Recall Response Form and return.",
      "product_quantity": "1640 kits",
      "distribution_pattern": "Domestic: IL, NC, VA, WY;",
      "openfda": {
        "device_name": "Custom Anesthesia Tray",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5120",
        "device_class": "2",
        "registration_number": [
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          "3015173212",
          "9616088"
        ],
        "fei_number": [
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          "3008552585",
          "3004076349",
          "3009888344",
          "1018470",
          "3004111573",
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        ]
      }
    }
  ]
}