{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "216312",
      "product_res_number": "Z-0183-2026",
      "event_date_initiated": "2025-09-04",
      "event_date_posted": "2025-10-16",
      "recall_status": "Open, Classified",
      "res_event_number": "97659",
      "product_code": "OJG",
      "product_description": "Medical convenience kits \n\nItem Number/Description\nHSLM53AB\tSPINE PACK\nMILM82A\tDTC LAMINECTOMY PACK (PS 209475)\nRCNA47B\tNEURO ANGIO 0246971\nSFLM54AB\tLAMINECTOMY PACK - 219659\nUDLM94AA\tLAMINECTOMY PACK - 206064\nUILM77AU\tLAMINECTOMY (PS 039500)\nUINR44P\tNEURO IR PERIPHERAL (PS 64405)\nUISH15AV\tSHUNT PACK (PS 039360)",
      "code_info": "ANLM40AG\nUDI-DI 191072232076\nLot 8192111\nBag serial number\n68195596;\n\nANPP15AR\nUDI-DI 191072214423\nLot 8024911\nBag serial number\n68055493;\n\nHSLM53AB\nUDI-DI 191072224095\nLot 8061111\nBag serial number\n68138767;\n\nMILM82A\nUDI-DI 191072231512\nLot 8361111\nBag serial number\n68576542;\n\nRCNA47B\nUDI-DI 191072228536\nLot 8441711\nBag serial number\n68680026;\n\nSFLM54AB\nUDI-DI 191072217400\nlot 8105511\nBag serial number\nN/A;\n\nUDLM94AA\nUDI-DI 191072214089\nLot 8382011\nBag serial number\n17621919;\n\nUILM77AU\nUDI-DI 191072210333\nLot 8056311\nBag serial number\nN/A;\n\nUINR44P\nUDI-DI 191072210340\nLot 8067511\nBag serial numbers\n68138618\n68140374;\n\nUISH15AV\nUDI-DI 191072227843\nLot 8028211\nBag serial number\n68154067\n\n* If bag serial number is listed as \"N/A\", then whole lot is affected",
      "firm_fei_number": "3007069947",
      "recalling_firm": "American Contract Systems Inc.",
      "address_1": "1601 Se Gateway Dr Ste 120 1601 Se Gateway Dr",
      "address_2": "Ste 120",
      "city": "Grimes",
      "state": "IA",
      "postal_code": "50111-5223",
      "additional_info_contact": "Marlene Jones\n470-280-4277",
      "reason_for_recall": "Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers.\n\nConsignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.",
      "product_quantity": "32,433 total",
      "distribution_pattern": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.",
      "openfda": {
        "registration_number": [
          "1423537",
          "1423395",
          "3002807314",
          "3009888344",
          "9680425",
          "1220477",
          "3010155661",
          "3005012805",
          "1047429",
          "3007456622",
          "1061124",
          "2433012",
          "1643817",
          "3011144486",
          "3015173212",
          "3016577622",
          "1030451",
          "3004122598",
          "1067162",
          "3014334038",
          "3009420598",
          "2029015",
          "3010635845",
          "3009337401",
          "1923569",
          "1123137",
          "3005595283",
          "3035642068",
          "3045816902",
          "1928237",
          "9616088",
          "3014925393",
          "3003418325",
          "3004911384",
          "3015443199",
          "3004111573",
          "3007329020"
        ],
        "fei_number": [
          "3002807314",
          "3009888344",
          "1220477",
          "3010155661",
          "3005012805",
          "1000160458",
          "3000717925",
          "3002902735",
          "1047429",
          "3007456622",
          "3001236905",
          "1000123180",
          "2433012",
          "1643817",
          "3011144486",
          "3015173212",
          "3016577622",
          "1030451",
          "3004122598",
          "3014334038",
          "1000512168",
          "3009420598",
          "3007596547",
          "3010635845",
          "3009337401",
          "1923569",
          "3005595283",
          "3035642068",
          "3045816902",
          "1928237",
          "3014925393",
          "3003418325",
          "3004911384",
          "3015443199",
          "3003831320",
          "3004111573",
          "3007329020"
        ],
        "device_name": "Neurological Tray",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4525",
        "device_class": "1"
      }
    }
  ]
}