{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "83113",
      "recalling_firm": "Pro-Dex Inc",
      "address_1": "2361 McGaw Ave",
      "address_2": "N/A",
      "postal_code": "92614-5831",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distributed in the states of CA, FL, MI, and TX, country of Finland.",
      "recall_number": "Z-2340-2019",
      "product_description": "PRO-DEX Surgical Driver Battery Pack PDBP-001 Series  PRO-DEX Battery Pack, Single Pouch - PDBP-001-2  PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2    Product Usage:  -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.",
      "product_quantity": "68 cases of 40 batteries = 2,720 individual batteries",
      "reason_for_recall": "Visual particulates within a battery Tyvek pouch.  The battery is provided sterile for use with surgical drivers.",
      "recall_initiation_date": "20180925",
      "center_classification_date": "20190822",
      "termination_date": "20220420",
      "report_date": "20190828",
      "code_info": "PDBP-001 Series  Model: PDBP-040-2 (40ct PDBP-001-2) which are 40 count batteries.  Lot(s): K098N (61900), K0B3F (62625)    K098N and K0B3F are Pro-Dex lot numbers.  61900 and 62625 are the contract packager's lot numbers    UDI Code: (01) 0 0860540 00025 6"
    }
  ]
}