{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "221638",
      "product_res_number": "Z-2989-2026",
      "event_date_initiated": "2026-05-19",
      "event_date_posted": "2026-08-20",
      "recall_status": "Open, Classified",
      "res_event_number": "99482",
      "product_code": "OJG",
      "product_description": "American Contract Systems medical procedure kits and trays labeled as:  \n1) CRANI PACK - 208400, Model Item Number UDCP57AI; \n2) SPINE PACK, Model Item Number HSLM53AC; \n3) CRANIAL PACK - 205992, Model Item Number MHCP75AH; \n4) IMRI CRANI PACK - 213871, Model Item Number ANCI17AO; \n5) CRANI PACK - 205942, Model Item Number ANCP30AP; \n6) A-P PACK - 205936, Model Item Number ANAP22AP; \n7) POSTERIOR PACK - 205960, Model Item Number ANPP15AR; \n8) ANTERIOR CERVICAL PACK - 205935, Model Item Number ANAN51AI; \n9) LAMINECTOMY PACK - 205957, Model Item Number ANLM40AG.",
      "code_info": "Model/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8388111; \nModel/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8474311; \nModel/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8521711; \nModel/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8547611; \nModel/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8672411; \nModel/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8775211; \nModel/Item Number UDCP57AI, UDI/DI 191072216250, Lot Number 42-8810511; \nModel/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8447111; \nModel/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8548311; \nModel/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8630311; \nModel/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8785011; \nModel/Item Number HSLM53AC, UDI/DI 191072238207, Lot Number 42-8742911; \nModel/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8455911; \nModel/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8498111; \nModel/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8538111; \nModel/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8601211; \nModel/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8764511; \nModel/Item Number MHCP75AH, UDI/DI 191072211934, Lot Number 42-8823811; \nModel/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8384311; \nModel/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8525011; \nModel/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8611711; \nModel/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8705911; \nModel/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8798411; \nModel/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8831911; \nModel/Item Number ANCI17AO, UDI/DI 191072232052, Lot Number 42-8854511; \nModel/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8497911; \nModel/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8537311; \nModel/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8673211; \nModel/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8756411; \nModel/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8818611; \nModel/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8854011; \nModel/Item Number ANCP30AP, UDI/DI 191072232069, Lot Number 42-8869111; \nModel/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8497811; \nModel/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8588811; \nModel/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8666611; \nModel/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8730411; \nModel/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8785411; \nModel/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8833011; \nModel/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8854611; \nModel/Item Number ANAP22AP, UDI/DI 191072214287, Lot Number 42-8869611; \nModel/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8345311; \nModel/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8379411; \nModel/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8547011; \nModel/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8654511; \nModel/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8746311; \nModel/Item Number ANPP15AR, UDI/DI 191072214423, Lot Number 42-8801611; \nModel/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8401611; \nModel/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8611411; \nModel/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8611411A; \nModel/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8648311; \nModel/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8755811; \nModel/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8807911; \nModel/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8852311; \nModel/Item Number ANAN51AI, UDI/DI 191072232045, Lot Number 42-8869511; \nModel/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8384511; \nModel/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8545711; \nModel/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8634611; \nModel/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8707111; \nModel/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8789211; \nModel/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8831811; \nModel/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8853011; \nModel/Item Number ANLM40AG, UDI/DI 191072232076, Lot Number 42-8868811.",
      "firm_fei_number": "3008492337",
      "recalling_firm": "American Contract Systems Inc",
      "address_1": "85 Shaffer Park Dr",
      "city": "Tiffin",
      "state": "OH",
      "postal_code": "44883-9290",
      "additional_info_contact": "Marlene Jones\n470-280-4277",
      "reason_for_recall": "The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "American Contract Systems issued an \"URGENT: MEDICAL DEVICE FIELD CORRECTION\" on 5/19/2026 with a revision issued on 6/4/2026 via email.  The notice explained the issue, risks to health, and requested the consignee affix a recall label from the template provided to the exterior of the kit.  The label states:  \"URGENT: RECALL NOTIFICATION, Prior to use, remove & discard the Medicos Ritmed Neurological Sponge per ACS Recall FA-2026-034.\" Customers/end-users receiving the product through a distributor were directed to contact the distributor or sales representative with any questions.  Complete the Recall Response Form.\n\nDistributors were directed to directed to ensure all end-users are appropriately notified and maintain records of effectiveness.  \n\nIf you have any questions, contact the Regulatory Affairs Manager, Global Products by email: GM-OMRA_RECALLS@owens-minor.com or phone at: 470.280.4277 .",
      "product_quantity": "4789 kits",
      "distribution_pattern": "US distribution to states of:  MN, MO, IA",
      "openfda": {
        "registration_number": [
          "3014925393",
          "3007329020",
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        "fei_number": [
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        ],
        "device_name": "Neurological Tray",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4525",
        "device_class": "1"
      }
    }
  ]
}