{
  "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,
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  },
  "results": [
    {
      "cfres_id": "210457",
      "product_res_number": "Z-0280-2025",
      "event_date_initiated": "2024-09-23",
      "event_date_posted": "2024-10-31",
      "recall_status": "Open, Classified",
      "res_event_number": "95510",
      "product_code": "MOQ",
      "product_description": "KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000",
      "code_info": "Lot: REF/UDI-DI:\nK0UB9: KLS-BP2-001/00856482008122, KLS-BP2-040/10856482008129.\n\nKLS-SD-2000/00856482008115",
      "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": "800-562-6204",
      "reason_for_recall": "The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.",
      "root_cause_description": "Component design/selection",
      "action": "On 9/23/24, an \"URGENT\" recall notice was emailed to the customer informing of the product, issue, risk and actions to be taken. Customers were instructed to do the following:\n\n1) Please immediately cease distribution and use of these lots. Inventory and distribution records should be evaluated to ensure that affected product is removed from any potential point of use.\n\n2) Product should be returned to the recalling firm.\n\n3) The Recall Acknowledgement and Return Form should be completed and returned via email to Recall@Pro-Dex.com or FAX 949.769.3281. \n\nQuestions or concerns can be directed to the firm at 949-769-3200 or Recall@Pro-Dex.com",
      "product_quantity": "2000",
      "distribution_pattern": "US distribution to FL only.",
      "openfda": {
        "k_number": [
          "K081713",
          "K013133",
          "K980224"
        ],
        "registration_number": [
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        "device_name": "Battery, Replacement, Rechargeable",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4820",
        "device_class": "1"
      }
    }
  ]
}