{
  "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": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
    }
  },
  "results": [
    {
      "cfres_id": "192762",
      "product_res_number": "Z-1036-2022",
      "event_date_initiated": "2022-03-22",
      "event_date_created": "2022-05-06",
      "recall_status": "Open, Classified",
      "res_event_number": "89868",
      "product_code": "OJG",
      "product_description": "1) ACS Spine Pack\n\n2) ACS Lumbar/Back Set Up Tray",
      "code_info": "1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613\n\n2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280",
      "firm_fei_number": "3003419114",
      "recalling_firm": "American Contract Systems, Inc.",
      "address_1": "2610 Ne Industrial Dr Ste 220 2610 Ne Industrial Dr",
      "address_2": "Ste 220",
      "city": "Kansas City",
      "state": "MO",
      "postal_code": "64117-2648",
      "additional_info_contact": "Suzanne Thomas\n470-280-4277",
      "reason_for_recall": "Product was sterilized with a higher than specification EO concentration.",
      "root_cause_description": "Process control",
      "action": "A customer letter dated 04/05/2022 was issued to impacted consignees.  The letter instructs the following:\n1) Review your inventory and segregate affected product. This product should not be shipped out to customers.\n2) Return affected product to 2610 NE Industrial Drive, Suite 220, Kansas City, MO 64120.\n3) If product was already further distributed, ensure that all downstream customers are properly notified of the recall and maintain records of effectiveness.\n\nA Field Action Response Form should be completed and returned to suzanne.thomas@hyh.com, even if you do not have product inventory.",
      "product_quantity": "72 packs",
      "distribution_pattern": "US Nationwide distribution in the states of IL, MO, NE, and TX.",
      "openfda": {
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        "device_name": "Neurological Tray",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4525",
        "device_class": "1"
      }
    }
  ]
}