{
  "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": "216280",
      "product_res_number": "Z-0171-2026",
      "event_date_initiated": "2025-09-04",
      "event_date_posted": "2025-10-16",
      "recall_status": "Open, Classified",
      "res_event_number": "97659",
      "product_code": "FDE",
      "product_description": "Basic Biopsy Tray;\nItem Number/Description:\nAKRB26D\nROBOTIC,\nAMGL09AA\nGENERAL LAPAROSCOPY,\nANLC35AD\nLAP CHOLE PACK - 205956,\nANLP25AJ\nLAPROSCOPY PACK - 205958,\nFYLA38E\nLAPCHOLAPPY PACK,\nIHDA88AH\nDIVINCI GYN URO,\nIHLC11AE\nLAP GENERAL PACK,\nMHLP45AJ\nLAPAROSCOPY PACK - 206005,\nMHRB88AO\nROBOTIC PACK - 242561,\nRCLC51C\nLAP CHOLE RCH 0246969,\nSMLC53C\nLAP CHOLE PACK,\nUDLC17AE\nDSC LAP CHOLE PACK - 206062,\nUIRU84AE\nROBOTIC UROLOGY PACK (PS 060571)",
      "code_info": "AKRB26D\nUDI-DI 191072229366\nLot 7350411\nBag Serial Number 68236939;\n\nAMGL09AA\nUDI-DI 191072207357\nLot 8459111\nBag Serial Numbers 68678361\n68678364;\n\nANLC35AD\nUDI-DI 191072211477\nLOT 8021911\nBag Serial Number n/a\nLot 8173811\nBag Serial Numbers \n17556328\n17556374\n17556376\n17556393;\n\nANLP25AJ\nUDI-DI 191072236333\nLot 8306311\nBag Serial Numbers \n47862596\n47862598;\n\nFYLA38E\nUDI-DI 191072203519\nLot 8134111\nBag Serial Number 17488260;\n\nIHDA88AH\nUDI-DI 191072226303\nLot 8096211\nBag serial number N/A\nLot 8150511\nBag Serial number 68277361;\n\nIHLC11AE\nUDI-DI 191072226372\nLot 8107911\nBag Serial Number N/A\nLot 8192711\nBag Serial Numbers\n68195543\n68196275;\n\nMHLP45AJ\nUDI-DI 191072236500\nLot 8527411\nBag serial number 68873222;\n\nMHRB88AO\nUDI-DI 191072236531\nLot 8322811\nBag serial number 68596086;\n\nRCLC51C\nUDI-DI 191072235930\nLot 8230311\nBag serial number N/A;\n\nSMLC53C\nUDI-DI 191072223029\nLot 8195611\nBag serial numbers\n68198164\n68198213\n68198222\n68198228\n68198229;\n\nUDLC17AE\nUDI-DI 191072214072\nLot 8501711\nBag serial number\n17744347;\n\nUIRU84AE\nUDI-DI 191072235565\nLot 8319311\nBag serial number\n68244060\n\n* If \"N/A\" for bag serial number, 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": {
        "device_name": "Laparoscopy Kit",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "k_number": [
          "K942677",
          "K912443",
          "K950924",
          "K955717"
        ],
        "registration_number": [
          "1423537",
          "1423395",
          "3009888344",
          "9611102",
          "3015895045",
          "3005012805",
          "1047429",
          "1055236",
          "1061124",
          "1043214",
          "3011137372",
          "2433012",
          "3013868968",
          "1060680",
          "1054241",
          "1643817",
          "3014325891",
          "3004605321",
          "3007289408",
          "3015173212",
          "3010041511",
          "3015058854",
          "3010885402",
          "1030451",
          "3011063460",
          "3004122598",
          "3015612252",
          "3008513424",
          "2029015",
          "2320762",
          "3001675293",
          "2431166",
          "1418479",
          "3045816907",
          "3005595283",
          "3035642068",
          "3016832577",
          "3045816902",
          "1928237",
          "9616088",
          "3014925393",
          "3003418325",
          "3004911384",
          "3004362278",
          "3015241782",
          "3004111573",
          "3007329020"
        ],
        "fei_number": [
          "3009888344",
          "3015895045",
          "3005012805",
          "1000160458",
          "3000717925",
          "3002902735",
          "1047429",
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          "2433012",
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          "1000208624",
          "1000112968",
          "3002808001",
          "3013868968",
          "1643817",
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          "3004605321",
          "3007289408",
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          "3010041511",
          "3015058854",
          "3010885402",
          "1030451",
          "3011063460",
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          "3003040625",
          "1000512168",
          "3008513424",
          "3005747797",
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          "3045816907",
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          "3005595283",
          "3035642068",
          "3016832577",
          "3045816902",
          "1928237",
          "3014925393",
          "3003418325",
          "3004911384",
          "3004362278",
          "3015241782",
          "3004111573",
          "3007329020"
        ]
      }
    }
  ]
}