{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "219098", "product_res_number": "Z-1924-2026", "event_date_initiated": "2026-03-16", "event_date_posted": "2026-04-22", "recall_status": "Open, Classified", "res_event_number": "98574", "product_code": "FYD", "k_numbers": [ "K894038" ], "product_description": "Flamingo Funnel Small, Model Number SQ20012-01", "code_info": "UDI-DI: 0860012888801;\nLot 8264701", "firm_fei_number": "3008493151", "recalling_firm": "SurgiSmoke Solutions", "address_1": "2300 Myrtle Ave Ste 200 2300 Myrtle Ave", "address_2": "Ste 200", "city": "Saint Paul", "state": "MN", "postal_code": "55114-1948", "additional_info_contact": "Morgan Evans\n281-3820523", "reason_for_recall": "Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.", "root_cause_description": "Packaging change control", "action": "An URGENT: MEDICAL DEVICE RECALL notification letter was sent to customers beginning 3/16/26.\n\nActions to be taken by the Customer/End User: \n1.\tImmediately discontinue use of this product. Note: The lots listed in this notice are the only lots impacted. All subsequently built product contains a correct, gamma compatible drape. \n2.\tDispose of impacted product according to local and national waste disposal procedures. Note: ALL PRODUCT MUST BE ACCOUNTED FOR ON THE MEDICAL DEVICE RECALL RETURN RESPONSE ACKNOWLEDGEMENT AND RECEIPT FORM. \n3.\tAcknowledge receipt of this notice. Complete and return the attached Medical Device Recall Return Response Acknowledgement and Receipt Form via phone, US Mail, or email even if you no longer have any affected product in inventory:\nPhone: Communicate the information required in the attached form by calling the toll free number: 1-800-557-3698 - available M-F between 8:00AM and 6:00PM CST \nUS Mail: Complete the attached form, and mail it back using the enclosed self-addressed, stamped envelope (if notice received by mail)\nEmail: Complete the attached form and return it to quality@surgismokesolutions.com\nPlease forward this notification to any additional customers to whom the affected product may have been distributed.\n\n\nType of Action by the Company: \nIn addition to this Recall activity, Nascent Surgical has initiated Corrective Action and Preventive Action measures that include but are not limited to: \nCorrecting the Bill of Materials to include a gamma compatible drape (completed Jan 2025)\nChanging the packaging configuration to remove the fold (completed Jan 2025) \nImproving Quality System Planning and other procedures to prevent recurrence \n\nOther Information: \nIf you have additional questions about this notice, please contact us: \nBy phone 1-800-557-3698 (toll free) - available M-F between 8:00AM and 6:00PM CST\nBy emailing quality@surgismokesolutions.com", "product_quantity": "2505 units total", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of CA, CO, GA, MA, MD, ME, MN, NH, NY, OH, TN, TX, and UT. The country of Canada.", "openfda": { "k_number": [ "K991167", "K930064", "K032400", "K894765", "K163659", "K191328", "K020510", "K930434", "K980915", "K896822", "K940266", "K924731", "K930061", "K920209", "K923799", "K920629", "K912612", "K943226", "K053464", "K930041", "K983364", "K902611", "K914118", "K131402", "K930040", "K182224", "K874512", "K930065", "K233789", "K912853", "K913036", "K930043", "K920210", "K043494", "K091139", "K200250", "K192035", "K935439", "K992361", "K912422", "K213068", "K052797", "K000904", "K924732", "K844087", "K990037", "K930066", "K912651", "K922555", "K920371", "K983298", "K930060", "K003840", "K930167", "K930450", "K930063", "K943227", "K952981", "K912347", "K142335", "K911154", "K930058", "K001082", "K202944", "K880890", "K894038", "K983333", "K930062", "K932230", "K012991", "K173108", "K973610", "K930059", "K970352", "K240127" ], "registration_number": [ "3015967359", "3045010542", "3019569846", "3012497308", "3009380063", "9681191", "1017294", "3013557562", "3004491689", "3026612481", "1043214", "3007305485", "3033509898", "1320894", "1061124", "1825014", "3005646850", "3027242374", "1718873", "9610773", "3012494290", "3003595343", "3007997036", "1721194", "1417592", "3025603301", "3008493151", "3007137643", "3018094310", "3011545081", "1526534", "3013188547", "3010601992", "9710582", "3043226252", "3036773433", "2320762", "3010230734", "1317202", "3036756245", "1035236", "2031894", "1043572", "1527736", "3008805497", "3012821221", "3013247477", "3016678045", "3020142587", "3005142514", "3010805941", "3011763071", "3002707546", "2032112", "1450908", "3008412416", "3030447506", "3007728276", "8030607", "3014579161", "1717344", "9680602", "2028523", "3009882464", "3003542872", "1836161", "3010400367", "3008132398", "2650143", "1058584", "1222993", "1450997", "3008786200", "3005075853" ], "fei_number": [ "3015967359", "3045010542", "3019569846", "3012497308", "3003040625", "3009380063", "1017294", "3013557562", "3006509795", "3004491689", "3026612481", "1000120578", "1043214", "3007305485", "3033509898", "1825014", "2648209", "3002750084", "3005646850", "3027242374", "1718873", "3008207730", "3003595343", "1000219637", "3012494290", "3003514332", "1417592", "3007997036", "1721194", "3025603301", "3008493151", "3007137643", "3018094310", "3011545081", "1526534", "3013188547", "3002807091", "3010601992", "3043226252", "3036773433", "3010230734", "1317202", "3036756245", "1035236", "1000125147", "1043572", "1527736", "1000268645", "3008805497", "3012821221", "3013247477", "3016678045", "3020142587", "3005142514", "3010805941", "3011763071", "3002707546", "1450908", "3001451571", "3008412416", "3030447506", "3007728276", "3014579161", "1717344", "3009882464", "3003542872", "3003076831", "3010400367", "1000512168", "1450997", "3008786200", "3002807798", "3005075853", "3001099558" ], "device_name": "Apparatus, Exhaust, Surgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.5070", "device_class": "2" } } ] }