{
  "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": "2026-09-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "197392",
      "product_res_number": "Z-0997-2023",
      "event_date_initiated": "2022-12-20",
      "event_date_posted": "2023-01-19",
      "recall_status": "Open, Classified",
      "res_event_number": "91292",
      "product_code": "MIH",
      "product_description": "RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX",
      "code_info": "UDI/DI 00843576100268:  REF 28-M4-22-190-22S, Lot Numbers: B210925203\nUDI/DI 00843576149731, REF 28-M4-24-150-24U, Lot Numbers:  2204210015, 2208250004, 2208250003;\nUDI/DI 00843576149618, REF 28-M4-26-095-26U, Lot Numbers:  2112210189; \nUDI/DI 00843576149748, REF 28-M4-26-155-26U, Lot Numbers:  2208240053, 2208250164, 2208220204;  \nUDI/DI 00843576100039, REF 28-M4-28-095-28S, Lot Numbers:  B220211367, B220129307, B220211163; \nUDI/DI 00843576149625, REF 28-M4-28-095-28U, Lot Numbers:  2208220081; \nUDI/DI 00843576150119, REF 28-M4-28-155-24U, Lot Numbers:  2210110060, 2202150279, 2202150279;\nUDI/DI 00843576100169, REF 28-M4-28-155-28S, Lot Numbers:  B220209262; \nUDI/DI 00843576149755, REF 28-M4-28-155-28U, Lot Numbers:  2208240183; \nUDI/DI 00843576150218, REF 28-M4-28-195-24U, Lot Numbers:  2202030119; \nUDI/DI 00843576149885, REF 28-M4-28-195-28U, Lot Numbers:  2109150299; \nUDI/DI 00843576150317, REF 28-M4-28-250-24U, Lot Numbers:  2202100029; \nUDI/DI 00843576150010, REF 28-M4-28-250-28U, Lot Numbers:  2202010127; \nUDI/DI 00843576100046, REF 28-M4-30-095-30S, Lot Numbers:  B220228338; \nUDI/DI 00843576149632, REF 28-M4-30-095-30U, Lot Numbers:  2208240127, 2112140029, 2202070140; \nUDI/DI 00843576150126, REF 28-M4-30-155-26U, Lot Numbers:  2203080218; \nUDI/DI 00843576100176, REF 28-M4-30-155-30S, Lot Numbers:  B220825157, B211229047, B220211164, B211228037; \nUDI/DI 00843576149762, REF 28-M4-30-155-30U, Lot Numbers:  2202100215, 2208240129;\nUDI/DI 00843576100633, REF 28-M4-30-200-26S, Lot Numbers:  B220207438; \nUDI/DI 00843576100305, REF 28-M4-30-200-30S, Lot Numbers:  B220118082; \nUDI/DI 00843576100732, REF 28-M4-30-250-26S, Lot Numbers:  B220202152; \nUDI/DI 00843576150027, REF 28-M4-30-250-30U, Lot Numbers:  2202030116; \nUDI/DI 00843576100053, REF 28-M4-32-095-32S, Lot Numbers:  B210910015; \nUDI/DI 00843576100541, REF 28-M4-32-155-28S, Lot Numbers:  B220301231; \nUDI/DI 00843576100183, REF 28-M4-32-155-32S, Lot Numbers:  B220216239; \nUDI/DI 00843576149779, REF 28-M4-32-155-32U, Lot Numbers:  2202100265, 2202110370; \nUDI/DI 00843576100640, REF 28-M4-32-200-28S, Lot Numbers:  B210626308, B210626307;  \nUDI/DI 00843576100749, REF 28-M4-32-250-28S, Lot Numbers:  B211222146; \nUDI/DI 00843576150331, REF 28-M4-32-250-28U, Lot Numbers:  2110120002; \nUDI/DI 00843576150034, REF 28-M4-32-250-32U, Lot Numbers:  2112180035; \nUDI/DI 00843576149656, REF 28-M4-34-100-34U, Lot Numbers:  2112110191, 2202120100, 2208230097; \nUDI/DI 00843576100558, REF 28-M4-34-145-30S, Lot Numbers:  B210609033; \nUDI/DI 00843576150140, REF 28-M4-34-145-30U, Lot Numbers:  2210110037; \nUDI/DI 00843576100190, REF 28-M4-34-145-34S, Lot Numbers:  B220210184, B211012027, B220210028,  B220216053, B220216053, B220209191; \nUDI/DI 00843576149786, REF 28-M4-34-145-34U, Lot Numbers:  2110120028,  2109150326, 2109140012, 2110120025, 2208240141, 2208240140, 2208240126, 2208240029, 2208240030, 2208250006, 2208250005, 2112280069, 2201280546, 2202080066;    \nUDI/DI 00843576100657, REF 28-M4-34-200-30S, Lot Numbers:  B210430260, B220217323, B220216055, B220217319, B211222145, B220216055, B210430262, B220216054;   \nUDI/DI 00843576150249, REF 28-M4-34-200-30U, Lot Numbers:  2202260090; \nUDI/DI 00843576100329, REF 28-M4-34-200-34S, Lot Numbers:  B210428257, B211014252;  \nUDI/DI 00843576149915, REF 28-M4-34-200-34U, Lot Numbers:  2202170286, 2202170286, 2202170219, 2202170278, 2202160200, 2202160200; \nUDI/DI 00843576100756, REF 28-M4-34-250-30S, Lot Numbers:  B211221199; \nUDI/DI 00843576100077, REF 28-M4-36-100-36S, Lot Numbers:  B220217276, B220217276;  \nUDI/DI 00843576100206, REF 28-M4-36-145-36S, Lot Numbers:  B221025248; \nUDI/DI 00843576100664, REF 28-M4-36-190-32S, Lot Numbers:  B210622126, B221025300; \nUDI/DI 00843576100763, REF 28-M4-36-250-32S, Lot Numbers:  B221007313; \nUDI/DI 00843576150058, REF 28-M4-36-250-36U, Lot Numbers:  2210110276, 2210100191;  \nUDI/DI 00843576100084, REF 28-M4-38-100-38S, Lot Numbers:  B220824128; \nUDI/DI 00843576150164, REF 28-M4-38-145-34U, Lot Numbers:  2202170235; \nUDI/DI 00843576100213, REF 28-M4-38-145-38S, Lot Numbers:  B221026208; \nUDI/DI 00843576100671, REF 28-M4-38-190-34S, Lot Numbers:  B220121067, B220317294;  \nUDI/DI 00843576150263, REF 28-M4-38-190-34U, Lot Numbers:  2204140072; \nUDI/DI 00843576100473, REF 28-M4-38-250-38S, Lot Numbers:  B220825007; \nUDI/DI 00843576100091, REF 28-M4-40-105-40S, Lot Numbers:  B220216195, B220216195,  B220125193; \nUDI/DI 00843576149687, REF 28-M4-40-105-40U, Lot Numbers:  2202160194; \nUDI/DI 00843576100589, REF 28-M4-40-145-36S, Lot Numbers:  B220825008; \nUDI/DI 00843576100350, REF 28-M4-40-195-40S, Lot Numbers:  B220222125,  B220222125, B220216224, B220223318, B220223318, B220216224;  \nUDI/DI 00843576100787, REF 28-M4-40-250-36S, Lot Numbers:  B221025298; \nUDI/DI 00843576150379, REF 28-M4-40-250-36U, Lot Numbers:  2203010243; \nUDI/DI 00843576149694, REF 28-M4-42-105-42U, Lot Numbers:  2109100260; \nUDI/DI 00843576100596, REF 28-M4-42-150-38S, Lot Numbers:  B220115098; \nUDI/DI 00843576100695, REF 28-M4-42-195-38S, Lot Numbers:  B220420138; \nUDI/DI 00843576149700, REF 28-M4-44-105-44U, Lot Numbers:  2201170430; \nUDI/DI 00843576100602, REF 28-M4-44-155-40S, Lot Numbers:  B220117359; \nUDI/DI 00843576100701, REF 28-M4-44-200-40S, Lot Numbers:  B220121070; \nUDI/DI 00843576100374, REF 28-M4-44-200-44S, Lot Numbers:  B220824149, B211229052,  B220115095;  \nUDI/DI 00843576150393, REF 28-M4-44-250-40U, Lot Numbers:  2201170418; \nUDI/DI 00843576150096, REF 28-M4-44-250-44U, Lot Numbers:  2112130139; \nUDI/DI 00843576100121, REF 28-M4-46-105-46S, Lot Numbers:  B211203109; \nUDI/DI 00843576149717, REF 28-M4-46-105-46U, Lot Numbers:  2203030290; \nUDI/DI 00843576100718, REF 28-M4-46-200-42S, Lot Numbers:  B220825037; \nUDI/DI 00843576100381, REF 28-M4-46-200-46S, Lot Numbers:  B220825038; \nUDI/DI 00843576149977, REF 28-M4-46-200-46U, Lot Numbers:  2204200130; \nUDI/DI 00843576100510, REF 28-M4-46-250-46S, Lot Numbers:  B210525287.",
      "firm_fei_number": "1000135961",
      "recalling_firm": "Bolton Medical Inc.",
      "address_1": "799 International Pkwy",
      "city": "Sunrise",
      "state": "FL",
      "postal_code": "33325-6220",
      "additional_info_contact": "Megan Indeglia\n954-626-5122",
      "reason_for_recall": "The product may be shorter than packaging indicates",
      "root_cause_description": "Labeling Change Control",
      "action": "On 12/15/2022, Terumo Aortic/Bolton Medical, Inc. issued an URGENT:  MEDICAL DEVICE RECALL notice to its consignees by mail.  The notice explained the problem and the risk, and requested the return of the device to a Terumo Sales Representative.",
      "product_quantity": "129 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.",
      "openfda": {
        "pma_number": [
          "P070007",
          "P040002",
          "P120006",
          "P990017",
          "P210032",
          "P110038",
          "P020018",
          "P020004",
          "P040043",
          "P110032",
          "P100040",
          "P140016",
          "P190015",
          "P070016",
          "P070027",
          "P200030",
          "P180001",
          "P150002",
          "P990020",
          "P200045",
          "P100021"
        ],
        "registration_number": [
          "9680271",
          "3006131984",
          "2247858",
          "3005580113",
          "3003678543",
          "2011171",
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          "3013164176",
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          "2017233"
        ],
        "fei_number": [
          "3006131984",
          "3005580113",
          "3003565456",
          "3003678543",
          "2011171",
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          "3007284313",
          "3016521833",
          "3003528016",
          "3002808486",
          "3008307705",
          "3004497303",
          "3002806434",
          "3005562917",
          "3013164176",
          "1000114185",
          "1000135961",
          "2017233"
        ],
        "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}