{
  "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": 3
    }
  },
  "results": [
    {
      "cfres_id": "218451",
      "product_res_number": "Z-1477-2026",
      "event_date_initiated": "2025-11-14",
      "event_date_posted": "2026-02-27",
      "recall_status": "Open, Classified",
      "res_event_number": "98359",
      "product_code": "FEO",
      "k_numbers": [
        "K171024"
      ],
      "product_description": "Brand Name: ShockPulse-SE Lithotripsy System SPL-SR\nProduct Name: ShockPulse-SE Lithotripsy System - Reusable Probes\nModel/Catalog Number: SPL-SR\nProduct Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.",
      "code_info": "Model/Catalog Number: SPL-SR;\nUDI: 00821925043824;\nSerial Numbers:  All;",
      "firm_fei_number": "2429304",
      "recalling_firm": "Olympus Corporation of the Americas",
      "address_1": "3500 Corporate Pkwy",
      "city": "Center Valley",
      "state": "PA",
      "postal_code": "18034-8229",
      "additional_info_contact": "Cynthia Ow\n647-9993203",
      "reason_for_recall": "Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.",
      "root_cause_description": "Device Design",
      "action": "On or about December 18, 2025 URGENT: MEDICAL DEVICE CORRECTION - UPDATE letters were sent to customers.\nEnsure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the new Supplemental Guidance.\nAdd a copy of this letter with the Supplemental Guidance to your existing Instruction for Use. You may continue to use the device according to this letter and the instruction for use, which cautions users to ensure that a back-up transducer and probe are sterilized and available prior to beginning a procedure. \nIf you have further distributed this product, identify and forward this notification to them.",
      "product_quantity": "602 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.",
      "openfda": {
        "k_number": [
          "K993046",
          "K182490",
          "K230893",
          "K142428",
          "K973251",
          "K920235",
          "K173234",
          "K181364",
          "K850298",
          "K181997",
          "K171024",
          "K873367",
          "K842024",
          "K843101"
        ],
        "device_name": "Lithotriptor, Ultrasonic",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.4480",
        "device_class": "2",
        "registration_number": [
          "3011050570",
          "3010202439",
          "3010707607",
          "2183744",
          "8030987",
          "2244478",
          "3014342096",
          "3006617533",
          "2020550",
          "2528981",
          "9610617",
          "3006546082",
          "3024021261",
          "9611102",
          "1648564",
          "3003790304",
          "9614434",
          "1220477",
          "3004096429",
          "3009420598",
          "2435119",
          "1519132"
        ],
        "fei_number": [
          "1000136269",
          "3011050570",
          "3010707607",
          "2183744",
          "3002808001",
          "3007475226",
          "3014342096",
          "3002808268",
          "3006617533",
          "3002808273",
          "2020550",
          "2528981",
          "3000205943",
          "3006546082",
          "3024021261",
          "3003790304",
          "1220477",
          "3004096429",
          "3002806910",
          "3009420598",
          "2435119",
          "1519132"
        ]
      }
    }
  ]
}