{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "191288",
      "product_res_number": "Z-0551-2022",
      "event_date_initiated": "2021-12-23",
      "event_date_created": "2022-02-01",
      "recall_status": "Open, Classified",
      "res_event_number": "89333",
      "product_code": "NJK",
      "pma_numbers": [
        "P180007"
      ],
      "product_description": "Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation\nModel Number: SVS-V9-00",
      "code_info": "Lot Number: WS147887-01\nUDI: 896506002309\nExpiration Date: 4/30/2024",
      "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": "SAME\n484-896-5000",
      "reason_for_recall": "Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)",
      "root_cause_description": "Labeling Change Control",
      "action": "Gyrus ACMI Inc. (Olympus) issued Urgent Medical Device Correction Letter dated 12/23/21. Letter states reason for recall, health risk and action to take:\nInspect your inventory for the referenced device and identify any devices with the model number\nand lot number specified above. Please check all areas of the hospital to determine if any of these\ndevices remain in inventory. Please contact Customer Service 1-888-524-7266, option 1, to obtain a\nReturn Material Authorization. Olympus will issue a credit or replacement to your facility for your\naffected product.\n2. Review your facility s use of the patient charge labels. If your facility has used these mislabeled\npatient charge labels in the patient s chart, or scanned into electronic medical records and/or patient\nimplant cards please request replacement labels by indicating the quantity in the Recall Portal (see\nStep 3). Olympus will ship replacement labels for you to use in correcting your patient records. In the\ncase of labels sent with patients at discharge for their personal records, include an explanation of the\nsituation as described above.\n3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number \"0403  and provide your contact information as indicated in the portal.\n\nAs you are most likely aware and as provided in the labeling for the product, for any subsequent procedures\nwith that patient, the SVS endobronchial valve size selection is based on patient anatomy using a sizing kit\n(SVS-VSK-06) and the fit is verified by a trained clinician after placement according to the product s instruction\nmanual. As a result, the mislabeled patient charge label was determined to not adversely affect medical\ntreatment. However, Olympus recognizes that there may be confusion about what product size was previously\nused and is therefore sending this notice to you.\nOlympus requests you to report any complaints, including product l",
      "product_quantity": "35 units",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.",
      "openfda": {
        "pma_number": [
          "P180007",
          "P180002"
        ],
        "registration_number": [
          "3007797756",
          "3004450998",
          "3019807891",
          "3015925639",
          "2011171",
          "3003790304",
          "1721676"
        ],
        "fei_number": [
          "3007797756",
          "3004450998",
          "3019807891",
          "3015925639",
          "2011171",
          "3003790304",
          "1721676"
        ],
        "device_name": "Valve, Pulmonary",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}