{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "85911",
      "product_res_number": "Z-0175-2010",
      "event_date_initiated": "2009-09-17",
      "event_date_posted": "2009-11-11",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-10-08",
      "res_event_number": "53582",
      "product_code": "FFK",
      "k_numbers": [
        "K012445"
      ],
      "product_description": "Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Natick, MA; REF/catalog no 840-733.",
      "code_info": "Lots 12723202, 12745667, 12767883, 12777930, 12782625, 12808559, 12813607, 12850772 and 12861508.",
      "firm_fei_number": "1828132",
      "recalling_firm": "Boston Scientific Corp",
      "address_1": "780 Brookside Dr",
      "city": "Spencer",
      "state": "IN",
      "postal_code": "47460-1080",
      "additional_info_contact": "866-868-4004",
      "reason_for_recall": "The label incorrectly reads \"compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)\" instead of bearing the correct statement \"compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170.\"",
      "root_cause_description": "Other",
      "action": "Consignees were notified by letter titled \"Urgent Medical Device Recall-Immediate Action Required\" dated 9/17/09 and instructed to cease using the product and to call the firm's customer service for return authorization. For additional information, call the firm at 866-868-4004.",
      "product_quantity": "173",
      "distribution_pattern": "Nationwide.",
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        "registration_number": [
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          "3001451463",
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        ],
        "device_name": "Lithotriptor, Electro-Hydraulic",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4480",
        "device_class": "2"
      }
    }
  ]
}