{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204949", "product_res_number": "Z-0696-2024", "event_date_initiated": "2023-11-07", "event_date_posted": "2024-01-10", "recall_status": "Open, Classified", "res_event_number": "93600", "product_code": "ETN", "k_numbers": [ "K112686" ], "product_description": "NIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes:\na) 8229706, 6.0MM ID; \nb) 8229707, 7.0MM ID; \nc) 8229708, 8.0MM ID; \nd) 8229736, 6MM ID 3PK; \ne) 8229737, 7MM ID 3 PK; \nf) 8229738, 8MM ID 3 PK", "code_info": "a) 8229706, GTIN 00643169782587, Serial Numbers: 0225892912, 0225894523, 0225904858, 0226227428, 0226246448, 0226246716, 0226253848, 0226258673, 0226276006, 0226294121, 0226299303, 0226299304, 0226321727, 0226350207, 0226604403, 0226628515, 0226648757, 0226684520, 0226718176, 0226745452; \nGTIN 00763000033941, Serial Numbers: 0225750658, 0225785080, 0225785081, 0225785083, 0225785085, 0225785587, 0225787473, 0225974682, 0225998102, 0225998104, 0226099513, 0226121951, 0226130941; \nb) 8229707, GTIN 00643169373099, Serial Numbers: 0225784379, 0225784380, 0225798573, 0225809609, 0225832077, 0225841439, 0225848733, 0225877835, 0225952300, 0225952301, 0225994034, 0226020502, 0226030100, 0226121428, 0226124551, 0226130051, 0226130055, 0226150740, 0226166004, 0226337996; \nGTIN 00643169782594, Serial Numbers: 0225798573, 0225803180, 0225805468, 0225805470, 0225824531, 0225825616, 0225828951, 0225832074, 0225832077, 0225841440, 0225846915, 0225846916, 0225848733, 0225848736, 0225848738, 0225849141, 0225869998, 0225870000, 0225877834, 0225877835, 0225886691, 0225915233, 0225915542, 0225921185, 0225929260, 0225929261, 0225932768, 0225934163, 0225952300, 0225952301, 0225956683, 0225962826, 0225972240, 0225980517, 0225983909, 0225983910, 0225994033, 0226003805, 0226004326, 0226012343, 0226012345, 0226020502, 0226020503, 0226020788, 0226030091, 0226030095, 0226030100, 0226043357, 0226057364, 0226057365, 0226057748, 0226057749, 0226079291, 0226084995, 0226086007, 0226086011, 0226086014, 0226086015, 0226097641, 0226102998, 0226112818, 0226115170, 0226124551, 0226130050, 0226130051, 0226139423, 0226149512, 0226157390, 0226157394, 0226166003, 0226166728, 0226166730, 0226177545, 0226185843, 0226186007, 0226194910, 0226203121, 0226209733, 0226232159, 0226232540, 0226246722, 0226252324, 0226276007, 0226278505, 0226279176, 0226300072, 0226300073, 0226321734, 0226321735, 0226337995, 0226337996, 0226350218, 0226352415, 0226352807, 0226352808, 0226376135, 0226385562, 0226389384, 0226389651, 0226397416, 0226398799, 0226398929, 0226406353, 0226406354, 0226406370, 0226406372, 0226441448, 0226452151, 0226455033, 0226455044, 0226512177, 0226553472, 0226591832; \nGTIN 00763000033958, Serial Numbers: 0225784378, 0225784379, 0225784380, 0225784381, 0225784382, 0225784383, 0225784384, 0225784385, 0225785406, 0225785407, 0225785408, 0225785410, 0225787474, 0225809609, 0225809610, 0225809612, 0225965501, 0225965502, 0225965503, 0226119539, 0226144158, 0226144159, 0226144160, 0226144161, 0226144162, 0226177144, 0226177145, 0226177687, 0226177688, 0226177689, 0226201784, 0226429408, 0226429410, 0226490525, 0226490808, 0226520885, 0226522308, 0226537201, 0226537203, 0226549613, 0226564997, 0226564998, 0226564999, 0226579984, 0226601698, 0226618838; \nc) 8229708, GTIN 00643169373105, Serial Numbers: 0225785422, 0225785424, 0225785467, 0225787472, 0226086712; \nGTIN 00763000033965, Serial Numbers: 0225785421, 0225785422, 0225785423, 0225785424, 0225785425, 0225785466, 0225785467, 0225785468, 0225787472, 0225809611, 0225975149, 0225998251, 0225998253, 0226004208, 0226004209, 0226086712, 0226121950, 0226130937, 0226130938, 0226130939; \nd) 8229736, GTIN 20763000041513, Serial Numbers: 0225998248; \ne) 8229737, GTIN 00763000041526, Serial Numbers: 0225908326, 0225908328, 0226103711; \nGTIN 20763000041520, Serial Numbers: 0225908183, 0225908184, 0225908185, 0225908326, 0225908327, 0225908328, 0225908329, 0225908330, 0225908332, 0225908334, 0226103711, 0226177141; \nf) 8229738, GTIN 20763000041537, Serial Numbers: 0225785470", "firm_fei_number": "1045254", "recalling_firm": "Medtronic Xomed, Inc.", "address_1": "6743 Southpoint Dr N", "city": "Jacksonville", "state": "FL", "postal_code": "32216-6218", "additional_info_contact": "Marie Gentile\n404-693-6028", "reason_for_recall": "Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,", "root_cause_description": "Under Investigation by firm", "action": "Medtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 11/07/2023 via 2-day UPS mailing. The notice explained the problem, the potential health risk, and requested segregation and quarantine pending return of the affected product. \nFor questions, contact: neuro-quality@medtronic.com.", "product_quantity": "80569 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K870272", "K051718", "K071349", "K091874", "K040543", "K933491", "K945242", "K020955", "K021595", "K133348", "K923056", "K982595", "K121931", "K925640", "K880720", "K873964", "K831715", "K232888", "K032083", "K912508", "K110712", "K934426", "K110696", "K014165", "K062549", "K843226", "K881757", "K072736", "K112686", "K031510", "K092729", "K003745", "K110138", "K152505", "K253536", "K063560", "K103128", "K991583", "K061365", "K110422", "K100992", "K934733", "K971143", "K895676", "K954601", "K212355", "K111597", "K110989", "K992869", "K874018", "K872791", "K895838", "K102862", "K925008", "K092292", "K093373", "K050162", "K150005", "K833646", "K063305", "K251672", "K781569", 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