BRANMOOR
THURSDAY · 14 MAY 2026

FDA Device Recall Z-1712-2026

Medline Industries, LP · Northfield, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107.

Lot / serial / GTIN: 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; 2. 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; 3. Medline SKU 70085107, UDI/DI each 10193489065961, UDI/DI case 20193489065968, Lot Numbers: 0000075384, 0000096807, 0000133033, 0000147541, 0000154518, 0000167033, 0000179525; 4. 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; 5. Medline SKU 70087107, UDI/DI each 10193489065992, UDI/DI case 30193489065996, Lot Numbers: 0000078897, 0000148131, 0000157141, 0000163681, 0000167174, 0000168020, 0000170851, 0000176075, 0000182252, 0000192254; 6. 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; 7. 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; 8. 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; 9. Medline SKU 70097007, UDI/DI each 10193489066067, UDI/DI case 30193489066061, Lot Numbers: 0000079553, 0000087472, 0000088541, 0000094831, 0000131995, 0000156391, 0000157135, 0000162685; 10. 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; 11. Medline SKU 70098107, UDI/DI each 10193489066104, UDI/DI case 30193489066108, Lot Numbers: 0000095693, 0000111595, 0000131985, 0000159175; 12. 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; 13. 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; 14. 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. 15. 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; 16. 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; 17. Medline SKU 80097107, UDI/DI each 10193489066906, UDI/DI case 30193489066900, Lot Numbers: 0000077040, 0000103845, 0000108241, 0000109897, 0000112900, 0000124191, 0000131659.

Quantity: 2630369 units

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.

Recall record

Recall number
Z-1712-2026
Classification
Class I
Status
Ongoing
Voluntary or mandated
Voluntary: Firm initiated
Firm notification
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution
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).
Recall initiated
2026-02-27
Classified by FDA Center
2026-04-07
FDA published
2026-04-15
Recalling firm
Medline Industries, LP
Firm location
Northfield, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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