{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "199020",
      "product_res_number": "Z-1391-2023",
      "event_date_initiated": "2023-02-14",
      "event_date_posted": "2023-04-14",
      "recall_status": "Open, Classified",
      "res_event_number": "91850",
      "product_code": "GET",
      "product_description": "KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2\n\nE-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.",
      "code_info": "Reference Number: PDEC-1000-2\nPart Number: A9671\nLot Numbers:\nK0C1B,\nK0D3P,\nK0E8T,\nK0FSD,\nK0HGV",
      "firm_fei_number": "2081135",
      "recalling_firm": "Pro-Dex Inc",
      "address_1": "2361 McGaw Ave",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92614-5831",
      "additional_info_contact": "Angel Domingo\n949-769-3200",
      "reason_for_recall": "Incorrect Unique Device Identifier/GTIN code was used on product.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On or about 11/08/2022, the firm contacted its customer to inform them that the Unique Device Identifier (UDI/GTIN) code was incorrectly utilized for the the Pro-Dex E-Coupling Adapter Assembly.\n\nCustomers are instructed to:\nImmediately cease distribution and us of the affected products.  Inventory and distribution records should be evaluated immediately to ensure that affected \n\nReturn the affected products to\nReturns Department (Recall CAPA-22-015)\nPro-Dex, Inc.\n2361 McGaw Avenue\nIrvine, California 92614 USA\n\nReference the \"Recall CAPA-22-015\" on the outside of the shipping box\n\nFor questions or concerns, contact the QARA group at Pro-Dex at 949-769-3200 or email Angel.Domingo@Pro-Dex.com",
      "product_quantity": "199 devices",
      "distribution_pattern": "U.S. Nationwide distribution in the state of FL.",
      "openfda": {
        "k_number": [
          "K954076",
          "K942987",
          "K955174",
          "K960473",
          "K872951",
          "K910071",
          "K790195",
          "K952463",
          "K833187",
          "K953433",
          "K832186",
          "K914753",
          "K863447",
          "K904578",
          "K832187",
          "K952300",
          "K840370",
          "K885066",
          "K800382",
          "K843498",
          "K832188",
          "K831675",
          "K953432"
        ],
        "registration_number": [
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        "fei_number": [
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          "3004264602",
          "1625507",
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          "1000219637",
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          "3005180920",
          "1000477302",
          "3022320321",
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          "3006509795",
          "3030956508",
          "3002750084",
          "2020601",
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          "3018094310",
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          "1017294",
          "3001451571",
          "3010141593",
          "2647580",
          "3004962786",
          "3003120897"
        ],
        "device_name": "Motor, Surgical Instrument, Pneumatic Powered",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4820",
        "device_class": "1"
      }
    }
  ]
}