{ "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": 19 } }, "results": [ { "cfres_id": "219145", "product_res_number": "Z-1712-2026", "event_date_initiated": "2026-02-27", "event_date_posted": "2026-04-07", "recall_status": "Open, Classified", "res_event_number": "98598", "product_code": "DXT", "k_numbers": [ "K873955" ], "product_description": "NAMIC Angiographic Syringe, labeled as follows: \n1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; \n2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; \n3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; \n4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; \n5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; \n6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; \n7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; \n8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; \n9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; \n10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; \n11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; \n12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; \n13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; \n14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; \n15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; \n16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; \n17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107.", "code_info": "1. Medline SKU 70075027, UDI/DI each 10193489065831, UDI/DI case 30193489065835, Lot Numbers: 0000077215, 0000079109, 0000082289, 0000084363, 0000090369, 0000107045, 0000114900, 0000120770, 0000122275, 0000125531, 0000125834, 0000132127, 0000132132, 0000135020, 0000135023, 0000137279, 0000141698, 0000141699, 0000144189, 0000147731, 0000149644, 0000151436; \n2. Medline SKU 70085007, UDI/DI each 10193489065954, UDI/DI case 30193489065958, Lot Numbers: 0000074193, 0000077204, 0000077974, 0000079512, 0000083156, 0000085956, 0000086070, 0000086483, 0000090174, 0000090816, 0000090917, 0000092492, 0000094095, 0000096914, 0000098330, 0000099425, 0000100711, 0000100826, 0000101994, 0000113588, 0000116407, 0000116708, 0000117321, 0000119569, 0000120349, 0000121439, 0000121700, 0000123467, 0000124590, 0000126063, 0000127845, 0000132989, 0000134342, 0000134345, 0000134741, 0000136418, 0000138294, 0000141336, 0000147492, 0000149666, 0000150547, 0000152486, 0000152797, 0000155541, 0000156129, 0000156574, 0000158566, 0000164128, 0000166270, 0000167879, 0000167880, 0000168660, 0000170215, 0000170237, 0000171147, 0000172275, 0000173410, 0000187298, 0000187601, 0000187638; \n3. Medline SKU 70085107, UDI/DI each 10193489065961, UDI/DI case 20193489065968, Lot Numbers: 0000075384, 0000096807, 0000133033, 0000147541, 0000154518, 0000167033, 0000179525; \n4. Medline SKU 70087007, UDI/DI each 0000075190, G4UDI/DI case 10193489065985, Lot Numbers: 0000075190, 0000075227, 0000078287, 0000089093, 0000090805, 0000090975, 0000093951, 0000094198, 0000094735, 0000096910, 0000101139, 0000101618, 0000105984, 0000106005, 0000107037, 0000109850, 0000110377, 0000111490, 0000111537, 0000112994, 0000113248, 0000113383, 0000113633, 0000117395, 0000121309, 0000122108, 0000123468, 0000124591, 0000127017, 0000128278, 0000129370, 0000130125, 0000132167, 0000134842, 0000138681, 0000140049, 0000153343, 0000156539, 0000157741, 0000159414, 0000166268, 0000167626, 0000167639, 0000169163, 0000172756, 0000176061, 0000178804, 0000182016, 0000186160, 0000187605; \n5. Medline SKU 70087107, UDI/DI each 10193489065992, UDI/DI case 30193489065996, Lot Numbers: 0000078897, 0000148131, 0000157141, 0000163681, 0000167174, 0000168020, 0000170851, 0000176075, 0000182252, 0000192254; \n6. Medline SKU 70088007, UDI/DI each 10193489066012, UDI/DI case 30193489066016, Lot Numbers: 0000077187, 0000086247, 0000090162, 0000095619, 0000104749, 0000109521, 0000119070, 0000122098, 0000125541, 0000135421, 0000138529, 0000141833, 0000156061, 0000157744, 0000161113, 0000163952, 0000168023, 0000172923, 0000178145, 0000186934; \n7. Medline SKU 70095007, UDI/DI each 10193489066036, UDI/DI case 30193489066030, Lot Numbers: 0000074195, 0000077218, 0000078891, 0000083117, 0000084495, 0000086795, 0000088301, 0000089971, 0000096912, 0000109777, 0000114876, 0000118512, 0000118674, 0000120001, 0000120780, 0000121233, 0000121698, 0000122711, 0000128697, 0000131996, 0000135597, 0000137025, 0000138175, 0000140916, 0000147679, 0000150532, 0000159176, 0000161098, 0000161137, 0000166266, 0000167160, 0000170152; \n8. Medline SKU 70095107, UDI/DI each 10193489066043, UDI/DI case 30193489066047, Lot Numbers: 0000088193, 0000090703, 0000091441, 0000108589, 0000112295, 0000113957, 0000114591, 0000114910, 0000116253, 0000117305, 0000121678, 0000122871, 0000125011, 0000125016, 0000126248, 0000132001, 0000147323, 0000147489; \n9. Medline SKU 70097007, UDI/DI each 10193489066067, UDI/DI case 30193489066061, Lot Numbers: 0000079553, 0000087472, 0000088541, 0000094831, 0000131995, 0000156391, 0000157135, 0000162685; \n10. Medline SKU 70097107, UDI/DI each 10193489066074, UDI/DI case 30193489066078, Lot Numbers: 0000075365, 0000079731, 0000087346, 0000094790, 0000100287, 0000104614, 0000105597, 0000109564, 0000110688, 0000118408, 0000119439, 0000122041, 0000124165, 0000125525, 0000131987, 0000133030, 0000137305, 0000147507, 0000147678, 0000153736, 0000161611, 0000165564, 0000181799, 0000184713, 0000185058, 0000190607; \n11. Medline SKU 70098107, UDI/DI each 10193489066104, UDI/DI case 30193489066108, Lot Numbers: 0000095693, 0000111595, 0000131985, 0000159175; \n12. Medline SKU 80075027. UDI/DI each 10193489066739, UDI/DI case 30193489066733, Lot Numbers: 0000073773, 0000075166, 0000077039, 0000088354, 0000090588, 0000095298, 0000098304, 0000103809, 0000116987, 0000117782, 0000121306, 0000125285, 0000125804, 0000126247, 0000131716, 0000132243, 0000134967, 0000135264, 0000137714, 0000141733, 0000144473, 0000147785, 0000149296, 0000169772, 0000175145, 0000176267, 0000181484, 0000188304, 0000189612, 0000190429, 0000192341; \n13. Medline SKU 80085007, UDI/DI each 10193489066838, UDI/DI case 30193489066832, Lot Numbers: 0000069912, 0000070209, 0000070784, 0000070861, 0000071257, 0000071264, 0000071267, 0000072311, 0000073893, 0000074209, 0000074673, 0000074674, 0000075332, 0000075764, 0000077366, 0000077812, 0000079410, 0000080614, 0000080615, 0000080915, 0000081405, 0000081771, 0000083753, 0000084309, 0000085601, 0000085648, 0000085686, 0000086214, 0000086721, 0000086834, 0000087070, 0000088596, 0000088657, 0000089423, 0000089903, 0000090105, 0000094136, 0000094420, 0000096230, 0000099930, 0000102515, 0000102993, 0000102995, 0000102996, 0000103488, 0000103555, 0000106721, 0000106964, 0000107510, 0000107536, 0000107959, 0000108049, 0000108050, 0000109430, 0000109592, 0000110369, 0000110800, 0000110820, 0000110918, 0000111345, 0000112227, 0000112968, 0000114117, 0000115122, 0000115130, 0000115133, 0000115715, 0000116669, 0000117287, 0000117333, 0000117592, 0000119131, 0000119132, 0000120359, 0000120378, 0000120379, 0000120477, 0000120926, 0000121795, 0000121799, 0000121856, 0000121863, 0000122659, 0000123853, 0000123896, 0000124655, 0000125050, 0000126181, 0000126182, 0000126183, 0000126184, 0000127096, 0000127134, 0000130082, 0000130189, 0000130543, 0000130888, 0000131003, 0000131298, 0000132780, 0000132835, 0000133210, 0000134869, 0000135426, 0000135751, 0000135757, 0000137216, 0000137259, 0000139521, 0000140407, 0000140436, 0000140460, 0000141378, 0000142312, 0000143949, 0000144525, 0000144816, 0000144858, 0000146335, 0000146688, 0000147279, 0000147758, 0000148526, 0000148881, 0000149157, 0000149356, 0000149534, 0000149591, 0000150043, 0000150047, 0000150277, 0000150927, 0000150974, 0000151304, 0000151311, 0000151562, 0000151735, 0000153278, 0000153284, 0000154621, 0000154788, 0000155411, 0000155753, 0000156008, 0000156801, 0000157245, 0000157352, 0000157358, 0000157585, 0000157587, 0000158717, 0000159713, 0000159723, 0000159984, 0000160326, 0000160371, 0000161181, 0000162113, 0000162661, 0000162717, 0000162771, 0000162801, 0000164285, 0000164301, 0000164302, 0000165507, 0000165537, 0000166941, 0000167627, 0000168370, 0000168574, 0000170238, 0000170490, 0000170657, 0000170658, 0000170774, 0000172184, 0000172253, 0000172513, 0000172514, 0000172515, 0000172517, 0000172518, 0000173418, 0000173434, 0000173451, 0000174052, 0000174053, 0000174725, 0000174726, 0000174727, 0000175214, 0000175215, 0000175384, 0000175424, 0000175529, 0000176612, 0000176730, 0000176735, 0000176752, 0000177132, 0000177400, 0000177401, 0000177413, 0000177961, 0000178119, 0000178736, 0000179115, 0000179339, 0000179394, 0000179845, 0000179890, 0000179892, 0000179934, 0000180103, 0000180117, 0000180167, 0000181513, 0000181515, 0000181778, 0000181916, 0000182018, 0000182891, 0000182911, 0000183051, 0000183052, 0000183327, 0000183346, 0000183527, 0000184160, 0000184623, 0000185644, 0000185648, 0000185650, 0000185749, 0000185759, 0000185769, 0000186949, 0000186950, 0000187389, 0000187394, 0000187519, 0000187575, 0000187576, 0000187577, 0000187578, 0000187579, 0000188490, 0000188841, 0000188887, 0000188910, 0000189111, 0000189112, 0000189155, 0000189196, 0000189197; \n14. Medline SKU 80087007, UDI/DI each 10193489066852, UDI/DI case 30193489066856, Lot Numbers: 0000069251, 0000069917, 0000069924, 0000069955, 0000072771, 0000077785, 0000077961, 0000080251, 0000080640, 0000081441, 0000081509, 0000082978, 0000083583, 0000084511, 0000085710, 0000086143, 0000087262, 0000088591, 0000089167, 0000089223, 0000089900, 0000090951, 0000092215, 0000092427, 0000093891, 0000094516, 0000094933, 0000095447, 0000095467, 0000096380, 0000097051, 0000099609, 0000099610, 0000103018, 0000103037, 0000103071, 0000106714, 0000107645, 0000108268, 0000108568, 0000109958, 0000110755, 0000110822, 0000111582, 0000114281, 0000114307, 0000115713, 0000115967, 0000117330, 0000117797, 0000118671, 0000119940, 0000120026, 0000120051, 0000120053, 0000120316, 0000120975, 0000121434, 0000122584, 0000122603, 0000122604, 0000124663, 0000124680, 0000125249, 0000125286, 0000126308, 0000126556, 0000126585, 0000126586, 0000127955, 0000128344, 0000129498, 0000129499, 0000130238, 0000132000, 0000132003, 0000132374, 0000132699, 0000133607, 0000133695, 0000134500, 0000134502, 0000134897, 0000135265, 0000135316, 0000137719, 0000137820, 0000139116, 0000139172, 0000140262, 0000140397, 0000140962, 0000140966, 0000141839, 0000141861, 0000142855, 0000142869, 0000143982, 0000143993, 0000144660, 0000145515, 0000145586, 0000145926, 0000146475, 0000146982, 0000146986, 0000147169, 0000147982, 0000148028, 0000148577, 0000149312, 0000149318, 0000149583, 0000150969, 0000151045, 0000151063, 0000151741, 0000151761, 0000153191, 0000153280, 0000154083, 0000154130, 0000154176, 0000155027, 0000155028, 0000155581, 0000156012, 0000156816, 0000157314, 0000157315, 0000158415, 0000159552, 0000159560, 0000159582, 0000159978, 0000160369, 0000162471, 0000162480, 0000162481, 0000162624, 0000162625, 0000162649, 0000164092, 0000164096, 0000164097, 0000164098, 0000164291, 0000164356, 0000164369, 0000164412, 0000164549, 0000165293, 0000165504, 0000165591, 0000165654, 0000166238, 0000166269, 0000166502, 0000167633, 0000167696, 0000167868, 0000167920, 0000167921, 0000167958, 0000167971, 0000169151, 0000170064, 0000170157, 0000170159, 0000170191, 0000170618, 0000171787, 0000171814, 0000171818, 0000172763, 0000172766, 0000173231, 0000173232, 0000173233, 0000173234, 0000173247, 0000174297, 0000174299, 0000174312, 0000174326, 0000174327, 0000175651, 0000176231, 0000176507, 0000176617, 0000177589, 0000177957, 0000178097, 0000178099, 0000178800, 0000179118, 0000179119, 0000179357, 0000179358, 0000179359, 0000179906, 0000179922, 0000180197, 0000181163, 0000181815, 0000182069, 0000182717, 0000182776, 0000182777, 0000182835, 0000183531, 0000183532, 0000183591, 0000183662, 0000184146, 0000184178, 0000184332, 0000184352, 0000184776, 0000184777, 0000185117, 0000185118, 0000185660, 0000185661, 0000186183, 0000186212, 0000186254, 0000186265, 0000186566, 0000186876, 0000187378, 0000187393, 0000187532, 0000187533, 0000187581, 0000187583, 0000187602, 0000187628, 0000188843, 0000188844, 0000188889, 0000189198, 0000189242, 0000189684, 0000189685, 0000189686. \n15. Medline SKU 80095007, UDI/DI each 10193489066876, UDI/DI case 20193489066873, Lot Numbers: 0000105201, 0000106354, 0000112875, 0000114278, 0000123107, 0000125259, 0000143729, 0000145697, 0000157989, 0000161262, 0000162833, 0000162869, 0000164539, 0000172176, 0000172859, 0000176097, 0000178913, 0000181201, 0000181321, 0000185560; \n16. Medline SKU 80095107, UDI/DI each 10193489066883, UDI/DI case 30193489066887, Lot Numbers: 0000075353, 0000076807, 0000077845, 0000078909, 0000080922, 0000082325, 0000086417, 0000091879, 0000092505, 0000094737, 0000096686, 0000097481, 0000100824, 0000103008, 0000104795, 0000107307, 0000109907, 0000112016, 0000114170, 0000114589, 0000116629, 0000117564, 0000120313, 0000120991, 0000121734, 0000125013, 0000126525, 0000128345, 0000129428, 0000131286, 0000132103, 0000136454, 0000139380, 0000143033, 0000143195, 0000144687, 0000144688, 0000145834, 0000150810, 0000151611, 0000151728, 0000153307, 0000153320, 0000154923, 0000154924, 0000162864, 0000163305, 0000163526, 0000164371, 0000165157, 0000166286, 0000167026, 0000167219, 0000169149, 0000170143, 0000170163, 0000175479, 0000176026, 0000177587, 0000177606, 0000179362, 0000180730, 0000181132, 0000182200, 0000185658, 0000190518, 0000191423; \n17. Medline SKU 80097107, UDI/DI each 10193489066906, UDI/DI case 30193489066900, Lot Numbers: 0000077040, 0000103845, 0000108241, 0000109897, 0000112900, 0000124191, 0000131659.", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n866-359-1704", "reason_for_recall": "Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.", "root_cause_description": "Under Investigation by firm", "action": "Medline Industries, LP issued an \"URGENT MEDICAL DEVICE RECALL\" notice to its consignees on 2/27/2026 via USPS and email. The notice explained the issue, risk associated with syringe disconnection and loose connection, and request customers remove and destroy all Namic RA Syringes. Over-labels will be provided for any affected kits on hand stating that the affected syringes must be removed and discarded from further use. The only exception is in rare circumstances where angiography is urgently required, no alternative device is available, and postponing the procedure would place the patient at significant risk. \nRequired Action: Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. \n\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "2630369 units", "distribution_pattern": "Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).", "openfda": { "k_number": [ "K883452", "K962141", "K910873", "K924116", "K172694", "K042744", "K830754", "K991103", "K944875", "K061976", "K203004", "K830609", "K854310", "K161471", "K071691", "K031339", "K211564", "K833138", "K873687", "K253048", "K823340", "K162088", "K082212", "K904994", "K973230", "K190102", "K872472", "K192370", "K791782", "K090621", "K860204", "K890292", "K133600", "K152978", "K171646", "K182273", "K113133", "K023183", "K241109", "K951802", "K153141", "K152218", "K823238", "K251788", "K905819", "K823356", "K051799", "K822536", "K875324", "K182289", "K232388", "K171698", "K133189", "K083523", "K880310", "K173450", "K020333", "K072886", "K934086", "K151960", "K873410", "K872981", "K201395", "K082439", "K903495", "K042784", "K841493", "K193028", "K161505", "K790835", "K033881", "K873173", "K011991", "K873597", "K062168", "K984231", "K850861", "K991557", "K132928", "K140469", "K151300", "K173773", "K880987", "K955684", "K823190", "K863596", "K882329", "K834107", "K955685", "K913624", "K800613", "K900034", "K902221", "K150485", "K092896", "K191060", "K860842", "K070798", "K192657", "K120892", "K800823", "K013815", "K840281", "K113198", "K984088", "K895318", "K142745", "K252652", "K884913", "K903390", "K963982", "K880877", "K020892", "K040298", "K050456", "K150902", "K073592", "K072696", "K160107", "K901382", "K151746", "K933846", "K993774", "K902377", "K973334", "K851402", 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