{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "210339",
      "product_res_number": "Z-0287-2025",
      "event_date_initiated": "2024-09-18",
      "event_date_posted": "2024-11-01",
      "recall_status": "Open, Classified",
      "res_event_number": "95464",
      "product_code": "HBA",
      "k_numbers": [
        "K854714"
      ],
      "product_description": "Americot 20-01S (1/4\" x 1/4\") or 6mm x 6mm:  Neurological sponges for use in the protection of neural tissue during surgery.\nRef: 20-01S \n\n\n x  inches or 6mm x 6mm)\nComponent: N/A",
      "code_info": "UDI-DI: 10749915000039\n\nLot Number\tExpiration Date:\t\n2023/03 AQ\t2028/03/31;\t\n2023/06 AP\t2028/06/30;\t\n2023/10 BO\t2028/10/31;\t\n2023/12 AY\t2028/12/31;\t\n2024/05 AE\t2029/05/31;\n2024/06 AQ\t2029/06/30",
      "firm_fei_number": "1221144",
      "recalling_firm": "American Surgical Company, LLC",
      "address_1": "45 Congress St Ste 153 45 Congress St",
      "address_2": "Ste 153",
      "city": "Salem",
      "state": "MA",
      "postal_code": "01970-5998",
      "reason_for_recall": "Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.",
      "root_cause_description": "Process control",
      "action": "American Surgical issued Urgent Medical Device Recall Letter on 9/26/24 via email. Letter states reason for recall, health risk and action to take:\n\nEffective immediately, American Surgical Company, LLC (ASC) requests your assistance. We ask that all lots listed in the table above within your inventory immediately be discontinued for use. We also ask the inventory to be quarantined, counted, and discarded. \n\"\tReport any complaint to ASC Customer Service 1-800-343-0060 or email: customerservice@americansurgical.com \n\"\tThe product code and lot number can be found on the individual product pouch and carton. \n\"\tPlease respond to this request by the deadline in the form below and return the completed form to customerservice@americansurgical.com or Fax: 1-781-595-5460 even if you do not have any inventory that remains. \n\"\tIf you distribute this product, please forward them a copy of this communication and notify ASC Customer Service immediately.\n\nFurther information and support: \n\"\tFor general questions regarding this communication, contact Customer Service at 800-343-0060 between the hours of 8:30 am and 5:00 pm Eastern Time, Monday through Friday.",
      "product_quantity": "390 units",
      "distribution_pattern": "CA, IA, IL, MN, MO, NY, OH, VA\n\nForeign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK Italy",
      "openfda": {
        "k_number": [
          "K904514",
          "K962807",
          "K121822",
          "K014268",
          "K914600",
          "K993019",
          "K020736",
          "K031008",
          "K973083",
          "K073576",
          "K891993",
          "K062406",
          "K140369",
          "K112598",
          "K923027",
          "K854713",
          "K902921",
          "K770894",
          "K844594",
          "K193346",
          "K862494",
          "K970328",
          "K950647",
          "K880402"
        ],
        "registration_number": [
          "3030733800",
          "9612501",
          "1060680",
          "1055236",
          "3012494290",
          "3012421607",
          "3018094310",
          "3013298431",
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          "3003418325",
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          "1048735",
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          "1047843",
          "1043214",
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          "3011862887",
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          "3038718579",
          "1220477",
          "9680271",
          "1054241",
          "1055789",
          "3004950768",
          "2320762",
          "3013557562",
          "1221144",
          "9611024",
          "3027977504",
          "3005663073",
          "1219071"
        ],
        "fei_number": [
          "3030733800",
          "3003259710",
          "3003495548",
          "1000159144",
          "1000112877",
          "3012494290",
          "3012421607",
          "3018094310",
          "3013298431",
          "1000208624",
          "1417592",
          "3003418325",
          "1219313",
          "1000136269",
          "1048735",
          "3003040625",
          "1047843",
          "1043214",
          "1000112968",
          "3011089435",
          "3014334038",
          "3011862887",
          "1045254",
          "1000110991",
          "3038718579",
          "1220477",
          "3004950768",
          "3002807170",
          "3013557562",
          "1221144",
          "1000136478",
          "3027977504",
          "3005663073"
        ],
        "device_name": "Neurosurgical Paddie",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4700",
        "device_class": "2"
      }
    }
  ]
}