{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 2
    }
  },
  "results": [
    {
      "cfres_id": "194644",
      "product_res_number": "Z-1491-2022",
      "event_date_initiated": "2022-05-25",
      "event_date_created": "2022-08-01",
      "recall_status": "Open, Classified",
      "res_event_number": "90528",
      "product_code": "QEY",
      "k_numbers": [
        "K213422"
      ],
      "product_description": "EkoSonic Kit 135cm, 12cm TZ\n\nThe EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components.  They are placed into the respective trays and sealed in a Tyvek pouch.  The sealed pouches are placed inside the kit carton (box) and the product labels.",
      "code_info": "UPN: 500-56112  GTIN: 858593006264  Lot Numbers: 8035075263, 8035075264, 8035075265, 8035075266, 8035075267, 8035075268, 8035075269, 8035075270, 8035075271, 8035075272",
      "firm_fei_number": "3002095335",
      "recalling_firm": "Boston Scientific Corporation",
      "address_1": "1 Scimed Pl",
      "city": "Maple Grove",
      "state": "MN",
      "postal_code": "55311-1565",
      "additional_info_contact": "Rebecca KinKead Rubio\n763-494-1133",
      "reason_for_recall": "Product may be mislabeled.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The recalling firm notified affected consignees by telephone beginning May 25, 2022 to inform them of the potential of improperly packaged devices.  On May 26, 2022, customer notifications, including a letter, instructions and reply form) were sent to all affected accounts via FedEx Overnight Delivery.\n\nConsignees are asked to return any affected and unused devices to BSC. The field removal letter will provide customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form (RVTF) indicating they have received the field removal and followed the included instructions.",
      "product_quantity": "10 units",
      "distribution_pattern": "US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY",
      "openfda": {
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          "K241851",
          "K980957",
          "K051319",
          "K053432",
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          "K060422"
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        "registration_number": [
          "3038791046",
          "9681260",
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        ],
        "fei_number": [
          "3038791046",
          "3003094851",
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          "3002095335",
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          "3000335778",
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        ],
        "device_name": "Mechanical Thrombolysis Catheter",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5150",
        "device_class": "2"
      }
    }
  ]
}