{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Kalona",
      "address_1": "102 1st St S",
      "reason_for_recall": "A cover failed leak testing during validation testing of new needle guides from a replacement tool.",
      "address_2": "",
      "product_quantity": "177 boxes",
      "code_info": "Item: 639-026 - Biopsy Starter Kit for use with Esaote LA332 and SL332 transducers  Lot #'s M206950, M664690, M897110, M119380, M605540, M706720, M570610, M543670, M851530, M983170, M358570. M358570, M427660. M526300, M526300, M734570, M912740, and M664690.  Item 698-009: Biopsy Starter Kit for use with Zonare C9-3 transducers  M427370, M103030, A010473, M103030, M771190, M427390, M293590, M427370, M105150, M089260, M515370, M293580, M888920, M427370, M220960, M558420, M560740, M909270, M096330, M388690, M558220, M695400, M085550, M917410, M419650, M879530, M964370, M093020, M723180, and A010459  Item: 698-016   Biposy Bracket for use with Zonare C9-3 transducers  M567620 and M052860  Item 620-116   Biopsy Starter Kit for use with BK Medical 18L5 and 8870 transducers  M080890, M559550, M425050, M056610, M092800, M041630, M186540, M122250, M335740, M043310, M499390, M483250, M109060, M275630, M912150, A023904, M457560, M051670, M091360, M895560, A015235, M202260, M869430, M056610, M027090, M308820, M831280, M547370, M253050, M083160, and M865470",
      "center_classification_date": "20180822",
      "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of GA, KY, CA, NY , NJ, TX, IL, MA,  RI, AZ,  and IA  and countries of     Ukraine, Hong Kong, Italy, Netherlands, Switzerland, United Kingdom, Denmark, Germany, Belgium, Spain, Japan, China, and Canada",
      "state": "IA",
      "product_description": "CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.     Product Usage:  The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.",
      "report_date": "20180829",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Civco Medical Instruments Co. Inc.",
      "recall_number": "Z-2888-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "80704",
      "termination_date": "20201006",
      "more_code_info": "",
      "recall_initiation_date": "20180223",
      "postal_code": "52247-9589",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}