{
  "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": "Ongoing",
      "city": "Marlborough",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86476",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "300 Boston Scientific Way",
      "address_2": "N/A",
      "postal_code": "01752-1291",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and International distribution.",
      "recall_number": "Z-0286-2021",
      "product_description": "Hurricane RX Biliary Balloon Dilatation Catheter  Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960    The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to exert radial force to dilate narrow duct segments, as well as the Sphincter of Oddi.",
      "product_quantity": "15,062 devices distributed in US. 12,930 distributed OUS",
      "reason_for_recall": "RX tunnel component (black sheath) may detach from the catheter shaft due to lower bond strength.",
      "recall_initiation_date": "20200916",
      "center_classification_date": "20201023",
      "report_date": "20201104",
      "code_info": "Hurricane RX Dilation Balloon 4 mm 2 cm  UPN/REF # M00545890  GTIN # 08714729283805  Lot/Batch # 25509445, 25536219, 25612668, 25649812, 25704208  EXP Date Range 04/13/2022 - 06/13/2022    Hurricane RX Dilation Balloon 4 mm 4 cm  UPN/REF # M00545900  GTIN # 08714729283812  Lot/Batch #   25326198, 25344165, 25344168, 25366542, 25366543, 25379240,  25379241, 25392546, 25447687, 25447688, 25447689, 25447690,  25447691, 25447692, 25453103, 25453105, 25453108, 25466435,  25468596, 25468597, 25471588, 25479171, 25479176, 25479177,  25479178, 25479521, 25481983, 25481984, 25481985, 25481986,  25497466, 25497467, 25497468, 25506678, 25509440, 25509446,  25509447, 25509450, 25518274, 25518305, 25518314, 25533944,  25536416, 25536680, 25536860, 25543967, 25543969, 25571363,  25575934, 25575935, 25576717, 25576718, 25576719, 25576720,  25576721, 25576769, 25611564, 25612669, 25612670, 25612671,  25612673, 25612674, 25623377, 25623378, 25623379, 25623380,  25623381, 25623382, 25623383, 25623384, 25640115, 25649813,  25649816, 25678821, 25678826, 25678831, 25678836, 25680096,  25704209, 25704210, 25704211, 25704212, 25704213, 25704214,  25704215, 25704216, 25739146, 25739147, 25739149, 25739150,  25771761, 25771762, 25771765  EXP Date Range 02/07/2022 - 06/27/2022    Hurricane RX Dilation Balloon 6 mm 2 cm  UPN/REF # M00545910  GTIN #08714729283829  Lot/Batch # 25456946, 25497472, 25571369, 25623385, 25678822, 25739151  EXP Date Range 03/22/2022 - 06/20/2022    Hurricane RX Dilation Balloon 6 mm 4 cm  UPN/REF # M00545920  GTIN # 08714729283836  Lot/Batch # 25305803, 25326193, 25326194, 25326195, 25326199, 25334817,  25334818, 25366544, 25366545, 25366546, 25366547, 25392549,  25392551, 25392553, 25392554, 25392555, 25397943, 25397944,  25447697, 25447698, 25453106, 25453109, 25461680, 25466436,  25468598, 25472425, 25475235, 25475236, 25479172, 25479173,  25479179, 25481987, 25481988, 25481989, 25481990, 25481991,  25497469, 25497470, 25497473, 25497474, 25497475, 25509412,  25509413, 25509414, 25509451, 25509452, 25509453, 25518276,  25518306, 25518307, 25518315, 25518316, 25536681, 25536739,  25536740, 25543970, 25543971, 25543972, 25543973, 25571370,  25571373, 25576770, 25576771, 25576772, 25576773, 25576881,  25576882, 25576883, 25576884, 25576885, 25608762, 25623386,  25623387, 25623388, 25623389, 25623390, 25623391, 25623392,  25623393, 25623394, 25623395, 25623396, 25623397, 25623398,  25649814, 25649817, 25649820, 25649821, 25649825, 25649826,  25649830, 25649831, 25678823, 25678827, 25678832, 25678837,  25680097, 25704217, 25704218, 25704219, 25704220, 25704221,  25704222, 25704223, 25739152, 25739153, 25739154, 25739155,  25739157, 25739158, 25771773  EXP Date Range 02/02/2022 - 06/27/2022    Hurricane RX Dilation Balloon 8 mm 2 cm  UPN/REF # M00545930  GTIN # 08714729283843  Lot/Batch # 25509441, 25536741, 25644951, 25649190, 25650286, 25651334,  25654287  EXP Date Range 04/13/2022 - 05/31/2022    Hurricane RX Dilation Balloon 8 mm 4 cm  UPN/REF # M00545940  GTIN # 08714729283850  Lot/Batch # 25317077, 25326196, 25326220, 25326221, 25326222, 25334819,  25344169, 25366548, 25366549, 25392556, 25392557, 25397079,  25447693, 25447694, 25453104, 25453107, 25453110, 25466437,  25468599, 25471589, 25471590, 25475234, 25479174, 25479175,  25479520, 25479580, 25481992, 25497051, 25497052, 25502738,  25509415, 25509416, 25509417, 25509418, 25509419, 25509442,  25509448, 25509454, 25509546, 25518277, 25518278, 25518317,  25518318, 25536682, 25536742, 25536743, 25543975, 25543976,  25543977, 25543978, 25543979, 25544020, 25571371, 25571374,  25596599, 25602458, 25608760, 25612672, 25649815, 25649818,  25649822, 25649823, 25649827, 25649828, 25649832, 25649833,  25678824, 25678828, 25678829, 25678833, 25678834, 25678838,  25680098, 25680099, 25704224, 25704225, 25704226, 25704227,  25704228, 25704229, 25739159, 25739160, 25739161, 25739162,  25739163, 25739164, 25739165, 25739166, 25739167, 25739168,  25788242, 25789369, 25789801  EXP Date Range 02/04/2022 - 06/30/2022    Hurricane Rx Dilation Balloon 10 mm 2 cm  UPN/REF # M00545950  GTIN # 08714729283867  Lot/Batch # 25471587, 25571372, 25588303, 25673064  EXP Date Range 03/28/2022 - 06/06/2022    Hurricane RX Dilation Balloon 10 mm 4 cm  UPN/REF # M00545960  GTIN # 08714729283874  Lot/Batch # 25334980, 25344170, 25344171, 25366550, 25378999, 25397945,  25397950, 25447685, 25447695, 25447696, 25461681, 25464817,  25466438, 25471591, 25471592, 25484487, 25493901, 25497471,  25497476, 25509443, 25509444, 25509449, 25518279, 25518308,  25518309, 25536683, 25544022, 25544023, 25544024, 25544025,  25571375, 25602323, 25608761, 25640116, 25640117, 25644834,  25649819, 25649824, 25649829, 25649834, 25678825, 25678830,  25678835, 25678839, 25678880, 25680560, 25704230, 25704231,  25704232, 25739169, 25739170  EXP Date 02/08/2022 - 06/20/2022"
    }
  ]
}