{ "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": "210650", "product_res_number": "Z-0679-2025", "event_date_initiated": "2024-10-25", "event_date_posted": "2024-12-13", "recall_status": "Open, Classified", "res_event_number": "95574", "product_code": "EOQ", "k_numbers": [ "K223144" ], "product_description": "Galaxy bronchoscope (Product GALB-001) used with Instructions for use, Part: 10000752, part of the Noah Medical Galaxy System (GAL-001)", "code_info": "UDI-DI: 00850048825048. IFU Revision: J and all prior versions. All bronchoscope lots used with the following system serial numbers: CRB-1502, CRB-1503, CRB-1508, CRB-1513, CRB-1514, CRB-1515, CRB-1516, CRB-1518, CRB-1519, CRB-1520, CRB-1521, CRB-1522, CRB-1523, CRB-1524, CRB-1525, CRB-1528, CRB-1530, CRB-1532, CRB-1534, CRB-1535, CRB-1537, CRB-1538, CRB1540, CRB-1541, CRB-1543, CRB1554", "firm_fei_number": "3021325287", "recalling_firm": "Noah Medical", "address_1": "1501 Industrial Rd", "city": "San Carlos", "state": "CA", "postal_code": "94070-4111", "reason_for_recall": "Not all biopsy tools meant to fit bronchoscope channel (2.1mm inner diameter/length greater or equal to 1100mm) will pass through if scope channel positioned in sharp bend (approx. greater than 100-deg.), excessive force may result in tissue injury/pneumothorax; instruments with long rigid distal sections may exhibit insertion resistance when bronchoscope bending section significantly articulated.", "root_cause_description": "Device Design", "action": "On 10/25/24, recall notices were sent to customers who were asked to do the following:\n\nA copy of this letter should be kept with the instructions for use which adds additional warnings and precautions to the section Working Channel Tools/Instruments on page 23 of the Instructions for Use.\n\nCAUTION: If the bending section of the bronchoscope is articulated sharply and advancement of a biopsy tool encounters increased insertion resistance, straighten the bending section as much as possible to enable resumed advancement of the tool. Use of excessive force during instrument insertion may damage the instrument and/or the bronchoscope or result in tissue injury including pneumothorax. Certain instruments with longer rigid distal sections may exhibit increased insertion resistance when bronchoscope bending section is significantly articulated.\n\nFirm has undertaken an investigation of which types of biopsy tools are most likely to result in binding and will make this information available as testing is completed. A replacement to the Instructions for Use with the Cautions herein and replacement instructions will be made available. Firm is also investigating technical solutions to make the working channel of the bronchoscope compatible with a wider range of biopsy tools and a wide degree of conformations in use.\n\nShare this notification with any other healthcare professionals who may use the system.\n\nComplete and return the response form.\n\nFirm customer Service: customerservice@noahmed.com, 888-325-6624", "product_quantity": "26", "distribution_pattern": "US Nationwide Distribution: SC, OH, PA, TN, MO, IN, CA, WV, NY, MD, MA, NJ, ID, CT, NC", "openfda": { "k_number": [ "K221302", "K183516", "K250232", "K244017", "K131401", "K233671", "K252045", "K163537", "K983124", "K182253", "K950925", "K984157", "K983878", "K171291", "K893006", "K222014", "K142839", "K944649", "K952081", "K213235", "K151315", "K213782", "K832492", "K013731", "K252341", "K220957", "K050220", "K222861", "K233779", "K200678", "K202987", "K962380", "K981543", "K250863", "K121035", "K242793", "K061313", "K260382", "K022446", "K941264", 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