{
  "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": "Sunrise",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "91292",
      "recalling_firm": "Bolton Medical Inc.",
      "address_1": "799 International Pkwy",
      "address_2": "N/A",
      "postal_code": "33325-6220",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.",
      "recall_number": "Z-0997-2023",
      "product_description": "RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX",
      "product_quantity": "129 units",
      "reason_for_recall": "The product may be shorter than packaging indicates",
      "recall_initiation_date": "20221220",
      "center_classification_date": "20230119",
      "report_date": "20230125",
      "code_info": "UDI/DI 00843576100268:  REF 28-M4-22-190-22S, Lot Numbers: B210925203 UDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot Numbers:  2204210015, 2208250004, 2208250003; UDI/DI 00843576149618, REF 28-M4-26-095-26U, Lot Numbers:  2112210189;  UDI/DI 00843576149748, REF 28-M4-26-155-26U, Lot Numbers:  2208240053, 2208250164, 2208220204;   UDI/DI 00843576100039, REF 28-M4-28-095-28S, Lot Numbers:  B220211367, B220129307, B220211163;  UDI/DI 00843576149625, REF 28-M4-28-095-28U, Lot Numbers:  2208220081;  UDI/DI 00843576150119, REF 28-M4-28-155-24U, Lot Numbers:  2210110060, 2202150279, 2202150279; UDI/DI 00843576100169, REF 28-M4-28-155-28S, Lot Numbers:  B220209262;  UDI/DI 00843576149755, REF 28-M4-28-155-28U, Lot Numbers:  2208240183;  UDI/DI 00843576150218, REF 28-M4-28-195-24U, Lot Numbers:  2202030119;  UDI/DI 00843576149885, REF 28-M4-28-195-28U, Lot Numbers:  2109150299;  UDI/DI 00843576150317, REF 28-M4-28-250-24U, Lot Numbers:  2202100029;  UDI/DI 00843576150010, REF 28-M4-28-250-28U, Lot Numbers:  2202010127;  UDI/DI 00843576100046, REF 28-M4-30-095-30S, Lot Numbers:  B220228338;  UDI/DI 00843576149632, REF 28-M4-30-095-30U, Lot Numbers:  2208240127, 2112140029, 2202070140;  UDI/DI 00843576150126, REF 28-M4-30-155-26U, Lot Numbers:  2203080218;  UDI/DI 00843576100176, REF 28-M4-30-155-30S, Lot Numbers:  B220825157, B211229047, B220211164, B211228037;  UDI/DI 00843576149762, REF 28-M4-30-155-30U, Lot Numbers:  2202100215, 2208240129; UDI/DI 00843576100633, REF 28-M4-30-200-26S, Lot Numbers:  B220207438;  UDI/DI 00843576100305, REF 28-M4-30-200-30S, Lot Numbers:  B220118082;  UDI/DI 00843576100732, REF 28-M4-30-250-26S, Lot Numbers:  B220202152;  UDI/DI 00843576150027, REF 28-M4-30-250-30U, Lot Numbers:  2202030116;  UDI/DI 00843576100053, REF 28-M4-32-095-32S, Lot Numbers:  B210910015;  UDI/DI 00843576100541, REF 28-M4-32-155-28S, Lot Numbers:  B220301231;  UDI/DI 00843576100183, REF 28-M4-32-155-32S, Lot Numbers:  B220216239;  UDI/DI 00843576149779, REF 28-M4-32-155-32U, Lot Numbers:  2202100265, 2202110370;  UDI/DI 00843576100640, REF 28-M4-32-200-28S, Lot Numbers:  B210626308, B210626307;   UDI/DI 00843576100749, REF 28-M4-32-250-28S, Lot Numbers:  B211222146;  UDI/DI 00843576150331, REF 28-M4-32-250-28U, Lot Numbers:  2110120002;  UDI/DI 00843576150034, REF 28-M4-32-250-32U, Lot Numbers:  2112180035;  UDI/DI 00843576149656, REF 28-M4-34-100-34U, Lot Numbers:  2112110191, 2202120100, 2208230097;  UDI/DI 00843576100558, REF 28-M4-34-145-30S, Lot Numbers:  B210609033;  UDI/DI 00843576150140, REF 28-M4-34-145-30U, Lot Numbers:  2210110037;  UDI/DI 00843576100190, REF 28-M4-34-145-34S, Lot Numbers:  B220210184, B211012027, B220210028,  B220216053, B220216053, B220209191;  UDI/DI 00843576149786, REF 28-M4-34-145-34U, Lot Numbers:  2110120028,  2109150326, 2109140012, 2110120025, 2208240141, 2208240140, 2208240126, 2208240029, 2208240030, 2208250006, 2208250005, 2112280069, 2201280546, 2202080066;     UDI/DI 00843576100657, REF 28-M4-34-200-30S, Lot Numbers:  B210430260, B220217323, B220216055, B220217319, B211222145, B220216055, B210430262, B220216054;    UDI/DI 00843576150249, REF 28-M4-34-200-30U, Lot Numbers:  2202260090;  UDI/DI 00843576100329, REF 28-M4-34-200-34S, Lot Numbers:  B210428257, B211014252;   UDI/DI 00843576149915, REF 28-M4-34-200-34U, Lot Numbers:  2202170286, 2202170286, 2202170219, 2202170278, 2202160200, 2202160200;  UDI/DI 00843576100756, REF 28-M4-34-250-30S, Lot Numbers:  B211221199;  UDI/DI 00843576100077, REF 28-M4-36-100-36S, Lot Numbers:  B220217276, B220217276;   UDI/DI 00843576100206, REF 28-M4-36-145-36S, Lot Numbers:  B221025248;  UDI/DI 00843576100664, REF 28-M4-36-190-32S, Lot Numbers:  B210622126, B221025300;  UDI/DI 00843576100763, REF 28-M4-36-250-32S, Lot Numbers:  B221007313;  UDI/DI 00843576150058, REF 28-M4-36-250-36U, Lot Numbers:  2210110276, 2210100191;   UDI/DI 00843576100084, REF 28-M4-38-100-38S, Lot Numbers:  B220824128;  UDI/DI 00843576150164, REF 28-M4-38-145-34U, Lot Numbers:  2202170235;  UDI/DI 00843576100213, REF 28-M4-38-145-38S, Lot Numbers:  B221026208;  UDI/DI 00843576100671, REF 28-M4-38-190-34S, Lot Numbers:  B220121067, B220317294;   UDI/DI 00843576150263, REF 28-M4-38-190-34U, Lot Numbers:  2204140072;  UDI/DI 00843576100473, REF 28-M4-38-250-38S, Lot Numbers:  B220825007;  UDI/DI 00843576100091, REF 28-M4-40-105-40S, Lot Numbers:  B220216195, B220216195,  B220125193;  UDI/DI 00843576149687, REF 28-M4-40-105-40U, Lot Numbers:  2202160194;  UDI/DI 00843576100589, REF 28-M4-40-145-36S, Lot Numbers:  B220825008;  UDI/DI 00843576100350, REF 28-M4-40-195-40S, Lot Numbers:  B220222125,  B220222125, B220216224, B220223318, B220223318, B220216224;   UDI/DI 00843576100787, REF 28-M4-40-250-36S, Lot Numbers:  B221025298;  UDI/DI 00843576150379, REF 28-M4-40-250-36U, Lot Numbers:  2203010243;  UDI/DI 00843576149694, REF 28-M4-42-105-42U, Lot Numbers:  2109100260;  UDI/DI 00843576100596, REF 28-M4-42-150-38S, Lot Numbers:  B220115098;  UDI/DI 00843576100695, REF 28-M4-42-195-38S, Lot Numbers:  B220420138;  UDI/DI 00843576149700, REF 28-M4-44-105-44U, Lot Numbers:  2201170430;  UDI/DI 00843576100602, REF 28-M4-44-155-40S, Lot Numbers:  B220117359;  UDI/DI 00843576100701, REF 28-M4-44-200-40S, Lot Numbers:  B220121070;  UDI/DI 00843576100374, REF 28-M4-44-200-44S, Lot Numbers:  B220824149, B211229052,  B220115095;   UDI/DI 00843576150393, REF 28-M4-44-250-40U, Lot Numbers:  2201170418;  UDI/DI 00843576150096, REF 28-M4-44-250-44U, Lot Numbers:  2112130139;  UDI/DI 00843576100121, REF 28-M4-46-105-46S, Lot Numbers:  B211203109;  UDI/DI 00843576149717, REF 28-M4-46-105-46U, Lot Numbers:  2203030290;  UDI/DI 00843576100718, REF 28-M4-46-200-42S, Lot Numbers:  B220825037;  UDI/DI 00843576100381, REF 28-M4-46-200-46S, Lot Numbers:  B220825038;  UDI/DI 00843576149977, REF 28-M4-46-200-46U, Lot Numbers:  2204200130;  UDI/DI 00843576100510, REF 28-M4-46-250-46S, Lot Numbers:  B210525287."
    }
  ]
}