{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Santa Rosa",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "89935",
      "recalling_firm": "Medtronic Vascular, Inc.",
      "address_1": "3576 Unocal Pl",
      "address_2": "N/A",
      "postal_code": "95403-1774",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware,  District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, PUERTO RICO, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Croatia\tCyprus, Denmark, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom.",
      "recall_number": "Z-1042-2022",
      "product_description": "Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P\tADM04008013P\tADM04008013P\tADM04008013P\tADM04012013P\tADM04015013P\tADM04015013P\tADM04025013P\tADM05004013P\tADM05004013P\tADM05006013P\tADM05006013P\tADM05008013P\tADM05008013P\tADM05020013P\tADM06004013P\tADM06004013P\tADM06006013P\tADM06006013P\tADM06008013P\tADM06012013P\tADM06015013P\tADM06015013P\tADM06015013P\tADM06015013P\tADM07004013P\tADM07006013P\tADM07006013P\tADM07008013P    SBI04004013P\tSBI04008008P\tSBI04012013P\tSBI04015013P\tSBI05004008P\tSBI05006013P\tSBI05012008P\tSBI05012008P\tSBI05012013P\tSBI05015013P\tSBI06004008P\tSBI06004008P\tSBI06004013P\tSBI06004013P\tSBI06006008P\tSBI06006008P\tSBI06008008P\tSBI06008008P\tSBI06012013P\tSBI06012013S\tSBI06015013P\tSBI07004013P\tSBI08004013P\tSBI08008008S\tSBI10004008P",
      "product_quantity": "6, 035 units",
      "reason_for_recall": "Packaging for Balloon Catheters  may be damaged resulting in loss of sterility.",
      "recall_initiation_date": "20220323",
      "center_classification_date": "20220506",
      "report_date": "20220518",
      "code_info": "Model Number Lot Number GTIN ADM04004013P 0010935559 00643169383500, ADM04008013P 0010935575 00643169383524, ADM04008013P 0010935574 00643169383524, ADM04008013P 0010861910 00643169383524, ADM04012013P 0010968204 00643169383531, ADM04015013P 0010891542 00643169576315, ADM04015013P 0010975488 00643169576315, ADM04025013P 0010904889 00643169975064, ADM05004013P 0010861907 00643169383609, ADM05004013P 0010985886 00643169383609, ADM05006013P 0010863869 00643169383616, ADM05006013P 0010954041 00643169383616, ADM05008013P 0010990832 00643169383623, ADM05008013P 0010896018 00643169383623, ADM05020013P 0010904203 00643169975019, ADM06004013P 0010772773 00643169383258, ADM06004013P 0010947006 00643169383258, ADM06006013P 0010968232 00643169383265, ADM06006013P 0010968233 00643169383265, ADM06008013P 0010965798 00643169383272, ADM06012013P 0010891546 00643169859975, ADM06015013P 0010906058 00643169576353, ADM06015013P 0010930866 00643169576353, ADM06015013P 0010900221 00643169576353, ADM06015013P 0010846879 00643169576353, ADM07004013P 0010896015 00643169383340, ADM07006013P 0010863872 00643169383357, ADM07006013P 0010863871 00643169383357, ADM07008013P 0010926488 00643169383364, SBI04004013P 0011018180 00763000366513, SBI04008008P 0010735613 00643169740297, SBI04012013P 0010915831 00763000366605, SBI04015013P 0010947014 00643169740440, SBI05004008P 0010947013 00763000366650, SBI05006013P 0010982240 00763000366698, SBI05012008P 0010742135 00643169740396, SBI05012008P 0010947011 00763000366742, SBI05012013P 0010902109 00643169740402, SBI05015013P 0010863859 00643169740464, SBI06004008P 0010735615 00763000366803, SBI06004008P 0010885373 00763000366803, SBI06004013P 0010894506 00643169740181, SBI06004013P 0011018170 00643169740181, SBI06006008P 0010755363 00763000366834, SBI06006008P 0010982241 00763000366834, SBI06008008P 0010885372 00643169740334, SBI06008008P 0011018176 00643169740334, SBI06012013P 0011029688 00643169740426, SBI06012013S 0010875709 00763000137045, SBI06015013P 0010745656 00643169740488, SBI07004013P 0010926502 00643169740204, SBI08004013P 0010742136 00643169777712, SBI08008008S 0010864424 00763000136857, SBI10004008P 0010915833 00643169777880,"
    }
  ]
}